Exact FDA event identifier

Event 97879

16 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: October 24, 2025
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Edan Diagnostics

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

16 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 16

Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. Component: No

Z-1140-2026

Recall number: Z-1140-2026
Initiated: October 24, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Edan Diagnostics
Quantity: 3721

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Code information

EDAN Model: F3 UDI-DI code: 06944413800847 Serial/Lot Code: 460085-M16105760001 460085-M16105760002 460085-M16105760003 460085-M16105760004 460085-M16105760005 460085-M16105760006 460085-M16105760007 460085-M16105760008 460085-M16105760009 460085-M16105760010 460085-M16105760011 460085-M16105760012 460085-M16105760013 460085-M16105760014 460085-M16105760015 460085-M16105760016 460085-M16105760017 460085-M16105760018 460085-M16105760019 460085-M16105760020 460085-M16105760021 460085-M16105760022 460085-M16105760023 460085-M16105760024 460085-M16105760025 460085-M16105760026 460085-M16105760027 460085-M16105760028 460085-M16105760029 460085-M16105760030 460085-M16105760031 460085-M16105760032 460085-M16105760033 460085-M16105760034 460085-M16105760035 460085-M16105760036 460085-M16105760037 460085-M16105760038 460085-M16105760039 460085-M16105760040 460085-M16105760041 460085-M16105760042 460085-M16105760043 460085-M16105760044 460085-M16105760045 460085-M16105760046 460085-M16105760047 460085-M16105760048 460085-M16105760049 460085-M16105760050 460085-M16105760051 460085-M16105760052 460085-M16105760053 460085-M16803010001 460085-M16803010002 460085-M16803010003 460085-M16803010004 460085-M16803010005 460085-M16803010006 460085-M16803010007 460085-M16803010008 460085-M16803010009 460085-M16803010010 460085-M16803010011 460085-M16803010012 460085-M16803010013 460085-M16803010014 460085-M16803010015 460085-M16803010016 460085-M16803010017 460085-M16803010018 460085-M16803010019 460085-M16803010020 460085-M16803010021 460085-M16803010022 460085-M16803010023 460085-M16803010024 460085-M16803010025 460085-M16803010026 460085-M16803010027 460085-M16803010028 460085-M16803010029 460085-M16803010030 460085-M16803010031 460085-M16803010032 460085-M16803010033 460085-M16803010034 460085-M16803010035 460085-M16803010036 460085-M16803010037 460085-M16803010038 460085-M16803010039 460085-M16803010040 460085-M16803010041 460085-M16803010042 460085-M16803010043 460085-M16803010044 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Distribution pattern

Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.

device · product 2 of 16

Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. Component: No

Z-1141-2026

Recall number: Z-1141-2026
Initiated: October 24, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Edan Diagnostics
Quantity: 3518

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Code information

EDAN Model: F9 UDI-DI code: 06944413800434 Serial/Lot Numbers: 460430-M16105660001 460430-M16700280001 460475-M16605590001 460475-M16605590002 460475-M16605590003 460475-M16605590004 460475-M16806530001 460475-M16806530002 460476-M16B07550001 460476-M16B07550002 460476-M16B07550003 460476-M17402630001 460476-M17402630002 460476-M17402630003 460476-M17402630004 460476-M17402630005 460476-M17607650001 460476-M17607650002 460476-M17607650003 460476-M17607650004 460476-M17607650005 460476-M17607650006 460476-M17607650007 460476-M17607650008 460476-M17607650009 460476-M17607650010 460517-M16804200001 460688-M17A07770001 460688-M17A07770002 460688-M17A07770003 460723-M17904190001 460945-M18200660001 460945-M18200660002 460945-M18200660003 460945-M18200660004 460945-M18200660005 460945-M18200660006 460945-M18200660007 460945-M18200660008 460945-M18200660009 460945-M18200660010 460945-M18200660011 460945-M18200660012 460945-M18200660013 460945-M18200660014 460945-M18200660015 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560156-M17B10630021 560156-M17B10630022 560156-M17B10630023 560156-M17B10630024 560156-M17B10630025 560156-M17B10630026 560156-M17B10630027 560156-M17B10630028 560156-M17B10630029 560156-M17B10630030 560156-M17B10630031 560156-M17B10630032 560156-M17B10630033 560156-M17B10630034 560156-M17B10630035 560156-M17B10630036 EDAN Model: F9 Express UDI-DI code: 06944413800441 Serial/Lot Numbers: 560157-M15A03570001 460418-M15B07460001 460418-M16501740001 460418-M16405110001 460418-M16405110002 460418-M16405110003 460418-M16405110004 460418-M16405110005 460418-M16405110006 460418-M16405110007 460418-M16405110008 460418-M16405110009 460418-M16405110010 460418-M16405110011 460418-M16405110012 460288-M16702150001 460418-M16705790001 460418-M16705790002 460418-M16705790003 460418-M16705790004 460418-M16A07660001 460418-M16B00420001 460418-M16B00420002 460418-M16B00420003 460418-M16B00420004 460418-M16B00420005 460418-M16B00420006 460077-M16B04200001 460077-M16B04200002 460077-M16B04200003 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560039-M24706730007 560039-M24706730006 560039-M24706730001 560039-M24706730005 560039-M24706730003 560039-M24A17700001 560039-M24A17700002 560039-M24A17700007 560039-M24A17700008 560039-M24A17700009 560039-M24A17700003 560039-M24A17700004 560039-M24A17700005 560039-M24A17700006 560039-M24C01220001 560039-M24C01220002 560039-M24C01220005 560039-M24C01220018 560039-M24C01220019 560039-M24C01220007 560039-M24C01220009 560039-M24C01220013 560039-M24C01220014 560039-M24C01220016 560039-M24C01220003 560039-M24C01220004 560039-M24C01220006 560039-M24C01220010 560039-M24C01220017 560039-M24C01220008 560039-M24C01220011 560039-M24C01220012 560039-M24C01220015 560039-M24C01220020 560039-M24C15030003 560039-M24C15030011 560039-M24C15030004 560039-M24C15030005 560039-M24C15030001 560039-M24C15030006 560039-M24C15030009 560039-M24C15030010 560039-M24C15030002 560039-M24C15030007 560039-M24C15030008 560039-M24C18150001 461291-M25623120002 461291-M25623120004 461291-M25623120001 461291-M25623120003 EDAN Model: F6 UDI-DI code: 06944413800458 Serial/Lot Numbers: 560177-M15A03580001 560177-M15A03580002 560177-M15A03580003 560198-M15A03590001 560198-M15A03590002 560198-M15A03590003 560198-M15A03590004 560198-M15A03590005 560202-M15A03690001 560202-M15A03690002 560202-M15A03690003 560202-M15A03690004 560202-M15A03690005 560202-M15A03690006 560202-M15A06640001 560202-M15A06640002 560202-M15A06640003 560202-M15A06660001 560202-M15A06660002 560202-M15A06660003 560202-M15A06660004 560202-M15A06660005 560202-M15A06660006 560202-M15A06660007 560202-M15A06660008 560202-M15A06660009 560202-M15A06660010 560202-M15A06660011 5

Distribution pattern

Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.

device · product 3 of 16

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement. Component: No

Z-1142-2026

Recall number: Z-1142-2026
Initiated: October 24, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Edan Diagnostics
Quantity: 13934

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Code information

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360124-M20A11080090 360124-M20A11080088 360124-M20A11080071 360124-M20A11080070 360124-M20A11080053 360124-M20A11080035 360124-M20A11080034 360124-M20A11080028 360124-M20A11080005 360124-M20A11080004 360124-M20A11080100 360124-M20A11080099 360124-M20A11080092 360124-M20A11080091 360124-M20A11080085 360124-M20A11080084 360124-M20A11080083 360124-M20A11080079 360124-M20A11080072 360124-M20A11080066 360124-M20A11080048 360124-M20A11080044 360124-M20A11080038 360124-M20A11080022 360124-M20A11080036 360124-M20A11080017 360124-M20A11080010 360124-M20A11080026 360124-M20A11080019 360124-M20A11080012 360124-M20A1108001

Distribution pattern

Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.

device · product 4 of 16

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), and Quick TEMP/Infrared TEMP (TEMP). iM3 capabilities include storing, displaying measuring data. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. Component: No

Z-1143-2026

Recall number: Z-1143-2026
Initiated: October 24, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Edan Diagnostics
Quantity: 11987

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Code information

EDAN Model: iM3 UDI-DI code: 06944413808812 Serial/Lot Numbers: 261436-M19B06650005 261436-M19B06650003 261436-M19B06660007 261436-M19B06650002 261436-M19B06660001 261436-M19B06660004 261436-M19B06650001 261436-M19B06660008 261436-M19B06660003 261436-M19B06660002 261436-M19B06660006 261436-M19B06650004 261436-M19B06660010 261436-M19B06660005 261436-M19B06660009 261436-M19C16980011 261436-M19C16980013 261436-M19C16980002 261436-M19C16980004 261436-M19C16980006 261436-M19C16980012 261436-M19C16980009 261436-M19C16980010 261436-M19C16980015 261436-M19C16980003 261436-M19C16980005 261436-M19C16980008 261436-M19C16980001 261436-M19C16980007 261436-M19C16980014 261436-M20707940016 261436-M20707940014 261436-M20707940008 261436-M20707940002 261436-M20707940020 261436-M20707940006 261436-M20707940004 261436-M20707940001 261436-M20707940012 261436-M20707940018 261436-M20707940009 261436-M20707940010 261436-M20707940011 261436-M20707940003 261436-M20707940005 261436-M20707940013 261436-M20707940007 261436-M20707940015 261436-M20707940017 261436-M20707940019 261436-M20808640010 261436-M20808640006 261436-M20808640008 261436-M20808640003 261436-M20808640005 261436-M20808640009 261436-M20808640001 261436-M20808640002 261436-M20808640007 261436-M20808640004 261436-M20914760002 261436-M20914760025 261436-M20914760015 261436-M20914760024 261436-M20914760023 261436-M20914760020 261436-M20914760016 261436-M20914760014 261436-M20914760013 261436-M20914760001 261436-M20914760012 261436-M20914760011 261436-M20914760010 261436-M20914760007 261436-M20914760018 261436-M20914760017 261436-M20914760008 261436-M20914760006 261436-M20914760004 261436-M20914760003 261436-M20914760009 261436-M20914760005 261436-M20914760022 261436-M20914760021 261436-M20914760019 261478-M18208600001 261436-M20B13260015 261436-M20B13260048 261436-M20B13260044 261436-M20B13260035 261436-M20B13260049 261436-M20B13260046 261436-M20B13260042 261436-M20B13260028 261436-M20B13260025 261436-M20B13260022 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261436-M20B15440012 261436-M20B15440007 261436-M20B15440025 261436-M20C13740006 261436-M20B20350016 261436-M21108500009 261436-M21108510002 261436-M21108510001 261436-M21108500003 261436-M21108510015 261436-M21108510014 261436-M21108510013 261436-M21108510003 261436-M21108510004 261436-M21108510006 261436-M21108500002 261436-M21108500001 261436-M21108510005 261436-M21108510012 261436-M21108510011 261436-M21108510018 261436-M21108510020 261436-M21108500005 261436-M21108510010 261436-M21108510019 261436-M21108500006 261436-M21108500007 261436-M21108500004 261436-M21108500008 261436-M21108500010 261436-M21108510007 261436-M21108510008 261436-M21108510009 261436-M21108510016 261436-M21108510017 261436-M21318130004 261436-M21318130002 261436-M21318130040 261436-M21318130039 261436-M21318130033 261436-M21318130026 261436-M21318130016 261436-M21318130012 261436-M21318130031 261436-M21318130027 261436-M21318130025 261436-M21318130020 261436-M21318130011 261436-M21318130014 261436-M21318130021 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263126-M24817920014 263126-M24817920001 263126-M24816510017 263126-M24816510002 263126-M24719110034 263126-M24817920017 263123-M24816500014 263123-M24816500019 263126-M24817920007 263126-M24817920004 263126-M24816510014 263126-M24816510013 263123-M24816500018 263126-M24816510011 263126-M24817920009 263126-M24816510005 263123-M24816500020 263126-M24817920015 263126-M24816510006 263126-M24817920002 263126-M24719110032 263126-M24817920006 263126-M24817920013 263126-M24719110019 263125-M24708030015 263125-M24716440005 263123-M24816500015 263123-M24816500003 263125-M24708030020 263125-M24716440017 263125-M24716440006 263126-M24719110005 263125-M24716440020 263126-M24816510016 263126-M24719110028 263126-M24817920019 263126-M24817920018 263126-M24816510019 263126-M24816510012 263126-M24816510020 263126-M24816510010 263126-M24817920005 263125-M24708030013 263125-M24716440016 263125-M24708030001 263125-M24716440010 263125-M24716440004 263125-M24716440003 263125-M24716440001 263125-M24716440002 263126-M24817910015 263126-M24817910009 263126-M24817910016 263126-M24817920012 263126-M24817900016 263126-M24817910012 263126-M24817910003 263126-M24817910020 263126-M24817900011 263126-M24817900005 263126-M24817910002 263126-M24817910010 263126-M24817910013 263126-M24817910017 263126-M24817900020 263126-M24817910004 263126-M24817910001 263126-M24817900003 263126-M24817900009 263126-M24817900010 263126-M24817910007 263126-M24817900006 263126-M24817900004 263126-M24817900014 263126-M24817910018 263126-M24817900002 263126-M24817900007 263126-M24817900008 263126-M24817910005 263126-M24817910008 263126-M24817910

Distribution pattern

Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.

device · product 5 of 16

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts for multiple physiological parameters of adults and pediatrics. Component: No

Z-1144-2026

Recall number: Z-1144-2026
Initiated: October 24, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Edan Diagnostics
Quantity: 136

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Code information

EDAN Model: iM3s UDI-DI code: 06944413811171 Serial/Lot Numbers: 262825-H24701480005 262825-H24701480001 262825-H24701480002 262825-H24701480007 262825-H24701480010 262825-H24701480009 262825-H24701480008 262825-H24701480004 262825-H24701480003 262825-H24701480006 262825-H24802410006 262825-H24802410003 262825-H24802410007 262825-H24802410009 262825-H24802410010 262825-H24802410002 262825-H24802410005 262825-H24802410001 262825-H24802410008 262825-H24802410004 261573-M21708880001 261573-M21803610001 261573-M21C04280007 261573-M21C04280003 261573-M21C04280004 261573-M21C04280008 261573-M21C04280002 261573-M21C04280012 261573-M21C04280011 261573-M21C04280010 261573-M21C04280009 261573-M21C04280006 261573-M21C04280013 261573-M21C04280001 261573-M21C04280014 261573-M21C04280005 261573-M21C04280015 261573-M22701100009 261573-M22701100014 261573-M22701100019 261573-M22701100022 261573-M22701100025 261573-M22701100004 261573-M22701100021 261573-M22701100018 261573-M22701100008 261573-M22701100001 261573-M22701100020 261573-M22701100012 261573-M22701100005 261573-M22701100002 261573-M22701100011 261573-M22701100024 261573-M22701100013 261573-M22701100015 261573-M22701100023 261573-M22701100017 261573-M22701100007 261573-M22701100016 261573-M22701100006 261573-M22701100010 261573-M22701100003 262825-M23810180001 262825-M23810180002 261572-M20101720006 263089-H24503150005 263089-H24503150003 263089-H24503150006 263089-H24503150001 263089-H24503150010 263089-H24503150002 263089-H24503150014 263089-H24503150008 263089-H24503150009 263089-H24503150013 263089-H24503150012 263089-H24503150007 263089-H24503150011 263089-H24503150004 263089-H24503150015 262825-H25300480002 262825-H25300480001 263163-H25401870003 263163-H25401870004 263089-H25502070002 263089-H25502070016 263163-H25401870007 263163-H25401870008 263163-H25401870005 263163-H25401870001 263163-H25401870002 263163-H25401870006 263163-H25401870010 262825-H25502470009 263089-H25502070008 263089-H25502070012 263089-H25502070015 263089-H25502070013 263089-H25502070006 263089-H25502070011 263089-H25502070017 263089-H25502070019 263089-H25502070004 263163-H25401870009 263089-H25502070010 263089-H25502070009 263089-H25502070007 263089-H25502070001 263089-H25502070018 263089-H25502070005 263089-H25502070003 262825-H25502470003 262825-H25502470002 262825-H25502470008 262825-H25502470001 262825-H25502470005 262825-H25502470006 262825-H25502470007 263089-H25502070014 262825-H25502470004 262825-H25502470010 263089-H25701330006 263089-H25701330008 263089-H25701330013 263089-H25701330004 263089-H25701330012 263089-H25701330014 263089-H25701330002 263089-H25701330015 263089-H25701330010 263089-H25701330007 263089-H25701330003 263089-H25701330001 263089-H25701330009 263089-H25701330011 263089-H25701330005

Distribution pattern

Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.

device · product 6 of 16

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. Component: No

Z-1145-2026

Recall number: Z-1145-2026
Initiated: October 24, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Edan Diagnostics
Quantity: 14550

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Code information

EDAN Model: iM50 UDI-DI code: 06944413801622 Serial/Lot Numbers: 002327-M16803350001 002327-M16803350002 360069-M17707110001 333109-M16203920004 333109-M16203920005 333136-M16203910001 333136-M16203910002 333136-M16203910003 333136-M16203910004 333136-M16203910006 333136-M16203910007 333136-M16203910008 333136-M16203910009 333136-M16203910010 333136-M16203910005 333109-M16203920003 333109-M16203920002 333109-M16203920001 333109-M16802350004 333109-M16802350005 333109-M16802350006 333109-M16802350007 333109-M16802350008 333136-M16802360001 333136-M16802360002 333136-M16802360003 333136-M16802360004 333109-M16802350003 333136-M16802360005 333109-M16802350002 333109-M16802350001 333136-M16810700002 333136-M16810700003 333136-M16810700004 333136-M16810700005 333136-M16810700001 333136-M16A02590001 333136-M16A02590002 333136-M16A02590005 333136-M16A02590004 333136-M16A02590003 333136-M16A02590006 333136-M16A02590007 333136-M16A02590008 333136-M16A02590009 333136-M16A02590010 333136-M16B08530006 333136-M16B08530011 333136-M16B08530010 333136-M16B08530009 333136-M16B08530008 333136-M16B08530007 333136-M16B08530014 333136-M16B08530005 333136-M16B08530004 333136-M16B08530003 333136-M16B08530002 333136-M16B08530001 333109-M16B08540003 333109-M16B08540002 333109-M16B08540001 333136-M16B08530015 333136-M16B08530012 333136-M16B08530013 261054-M16C02640001 333136-M16B08550009 333136-M16B08550008 333136-M16B08550007 333136-M16B08550006 333136-M16B08550005 333136-M16B08550002 333136-M16B08550003 333136-M16B08550010 333136-M16B08550001 333109-M16B08560002 333109-M16B08560001 333136-M16B08550004 333136-M16B08550011 333136-M16B08550014 333136-M16B08550013 333136-M16B08550015 333136-M16B08550012 333109-M17201740005 333109-M17201740004 333109-M17201740003 333109-M17201740001 333109-M17201740002 261054-M17404380002 261054-M17404380001 261054-M17404380003 333152-M17606230003 333152-M17606230001 333152-M17606230004 333152-M17606230005 333152-M17606230002 333152-M17604540004 333152-M17604540005 333152-M17604540013 333152-M17604540007 333152-M17604540014 333152-M17604540001 333152-M17604540002 333152-M17604540010 333152-M17604540006 333152-M17604540012 333152-M17604540003 333152-M17604540011 333152-M17604540015 333152-M17604540008 333152-M17604540016 333152-M17604540009 333152-M17615040010 333152-M17615040004 333152-M17615040008 333152-M17615040003 333152-M17615040002 333152-M17615040005 333152-M17615040001 333152-M17615040009 333152-M17615040007 333152-M17615040006 333152-M17708870014 333152-M17708870004 333152-M17708870013 333152-M17708870005 333152-M17708870009 333153-M17708880003 333153-M17708880004 333153-M17708880005 333152-M17708870003 333152-M17708870011 333153-M17708880001 333152-M17708870001 333153-M17708880002 333152-M17708870012 333152-M17708870008 333152-M17708870006 333152-M17708870015 333152-M17708870007 333152-M17708870002 333152-M17708870010 333152-M17812870004 333153-M17812880003 333152-M17812870007 333152-M17812870006 333153-M17812880002 333152-M17812870001 333152-M17812870005 333152-M17812870003 333152-M17812870002 333153-M17812880001 333152-M17B07380003 333153-M17B07390010 333153-M17B07390009 333152-M17B07380007 333152-M17B07380005 333153-M17B07390007 333153-M17B07390005 333152-M17B07380014 333152-M17B07380013 333152-M17B07380011 333152-M17B07380004 333152-M17B07380009 333152-M17B07380015 333153-M17B07390004 333152-M17B07380006 333152-M17B07380002 333153-M17B07390008 333153-M17B07390002 333152-M17B07380010 333153-M17B07390003 333152-M17B07380012 333152-M17B07380008 333153-M17B07390001 333153-M17B07390006 333152-M17B07380001 261054-M17B09100003 261054-M17B09100002 261054-M17B09100004 261054-M17B09100001 333152-M18108230008 333152-M18108230007 333153-M18108210001 333153-M18108210002 333153-M18108210005 333152-M18108230001 261054-M18108220002 261054-M18108220001 333152-M18108230009 333152-M18108230005 333152-M18108230004 333152-M18108230010 333153-M18108210003 333153-M18108210004 333152-M18108230006 333152-M18108230003 333152-M18108230002 333152-M18407240003 333152-M18407240005 333152-M18407240002 261054-M18407250002 333152-M18407240001 261054-M18407250004 261054-M18407250003 261054-M18407250001 333152-M18407240004 261054-M18613120004 261054-M18613120003 333152-M18613390004 333152-M18613390005 333152-M18613390002 333152-M18613390001 261054-M18613120002 261054-M18613120001 333152-M18613390003 333152-M18803010006 333152-M18803010010 333152-M18803010004 261054-M18800810003 333152-M18803010002 261054-M18800810002 333152-M18803010007 333152-M18803010008 333152-M18803010009 261054-M18800810001 261054-M18800810004 333152-M18803010003 333152-M18803010001 333152-M18803010005 261054-M18901370001 261054-M18901370005 261054-M18901370007 261054-M18901370008 261054-M18901370003 261054-M18901370002 261054-M18901370006 261054-M18901370004 333152-M18A10630005 333153-M18A10640002 333152-M18A10630003 333153-M18A10640001 333152-M18A10630001 333152-M18A10630004 333152-M18A10630002 333152-M18C07440005 333152-M18C07440004 333152-M18C07440003 333152-M18C07440001 333152-M18C07440006 333152-M18C07440002 333152-M19306540002 333152-M19306540012 333152-M19306540001 333152-M19306540007 333152-M19306700003 333152-M19306700001 333152-M19306700006 333152-M19306540006 333152-M19306540008 333152-M19306540010 333152-M19306700007 333152-M19306540003 333152-M19306540004 333152-M19306540005 333152-M19306540011 333152-M19306540009 333152-M19306700008 333152-M19306700004 333152-M19306700002 333152-M19306700005 333153-M19306550002 333153-M19306550003 333153-M19306550008 333153-M19306550006 333153-M19306550007 333153-M19306550004 333153-M19306550009 333153-M19306550010 333153-M19306550001 333153-M19306550005 261054-M19403060003 261054-M19403060002 261054-M19403060001 333152-M19403070008 333152-M19403070007 333152-M19403070001 333152-M19403070006 333152-M19403070003 333152-M19403070005 333152-M19403070004 333152-M19403070002 333152-M19403070010 333152-M19403070009 333152-M19500980014 333152-M19500980001 333152-M19500980004 333152-M19500980011 333152-M19500980015 333152-M19500980005 333152-M19500980002 333152-M19500980009 333152-M19500980013 333152-M19500980012 333152-M19500980016 333152-M19500980019 333152-M19500980018 333152-M19500980020 333152-M19500980006 333152-M19500980010 333152-M19500980008 333152-M19500980007 333152-M19500980017 333152-M19500980003 261054-M19508910004 261054-M19508910005 261054-M19508910001 261054-M19508910002 261054-M19508910003 333153-M19612820005 333153-M19612820009 333153-M19612820010 333153-M19612820001 333153-M19612820007 333153-M19612820002 333152-M19612800017 333152-M19612800018 333152-M19612800020 333152-M19612800012 261054-M19612810003 261054-M19612810004 261054-M19612810001 261054-M19612810002 261054-M19612810005 333153-M19612820003 333152-M19612800010 333152-M19612800006 333152-M19612800011 333153-M19612820004 333152-M19612800019 333153-M19612820006 333152-M19612800002 333152-M19612800013 333152-M19612800014 333152-M19612800015 333153-M19612820008 333152-M19612800004 333152-M19612800005 333152-M19612800016 333152-M19612800001 333152-M19612800007 333152-M19612800008 333152-M19612800003 333152-M19612800009 333153-M19901430005 333153-M19901430004 333153-M19901430001 333153-M19901430003 333153-M19901430002 261924-M19B07110002 261924-M19B07110001 261924-M19B07110003 261924-M19B07110005 261924-M19B07110004 333152-M19C17220014 333152-M19C17220013 333152-M19C17220017 333152-M19C17220018 261924-M19C17210001 261924-M19C17210010 333152-M19C17220007 333152-M19C17220008 333152-M19C17220020 333152-M19C17220001 333152-M19C17220011 333152-M19C17220004 261924-M19C17210002 261924-M19C17210006 333152-M19C17220012 333152-M19C17220016 333152-M19C17220019 261924-M19C17210003 333152-M19C17220015 261924-M19C17210005 333152-M19C17220002 261924-M19C17210007 261924-M19C17210009 333152-M19C17220006 261924-M19C17210004 261924-M19C17210008 333152-M19C17220003 333152-M19C17220005 333152-M19C17220010 333152-M19C17220009 261924-M20206390001 333152-M20206380012 333152-M20206380002 261924-M20206390005 333152-M20206380020 333152-M20206380018 333152-M20206380011 333152-M20206380008 333152-M20206380001 333152-M20206380019 333152-M20206380016 333152-M20206380010 333152-M20206380004 333152-M20206380015 333152-M20206380005 261924-M20206390006 261924-M20206390004 261924-M20206390002 261924-M20206390008 261924-M20206390007 261924-M20206390003 333152-M20206380006 333152-M20206380009 333152-M20206380003 333152-M20206380017 333152-M20206380014 333152-M20206380013 333152-M20206380007 333153-M20310030004 333153-M20310030002 333152-M20310040004 333153-M20310030001 333153-M20310030003 333152-M20310040010 333152-M20310040002 333152-M20310040009 333153-M20310030005 333152-M20310040007 333152-M20310040008 333152-M20310040005 333152-M20310040006 333152-M20310040003 333152-M20310040001 333152-M20413530003 333152-M20413530017 333152-M20413530008 333152-M20413530002 333152-M20413530014 333152-M20413530005 333152-M20413530019 333152-M20413530011 333152-M20413530016 333152-M20413530020 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261200-M17907850002 261200-M17907850001 261200-M17A06240001 261200-M17A10550001 360069-M21C08280002 360069-M21C08280003 360069-M21C08280005 360069-M21C08280001 360069-M21C08280004 333153-M15B00590014 333153-M15B00590019 333153-M15B00590018 333153-M15B00590017 333153-M15B00590016 333153-M15B00590015 333153-M15B00590013 333153-M15B00590009 333153-M15B00590011 333153-M15B00590010 333153-M15B00590008 333153-M15B00590007 333153-M15B00590006 333153-M15B00590005 333153-M15B00590004 333153-M15B00590002 333153-M15B00590001 333153-M15B00590012 333153-M15B00590020 333153-M15B00590003 333153-M15C09980023 333153-M15C09980024 333153-M15C09980028 333153-M15C09980027 333153-M15C09980026 333153-M15C09980025 333153-M15C09980018 333153-M15C09980019 333153-M15C09980020 333153-M15C09980021 333153-M15C09980022 333153-M15C09980030 333153-M15C09980029 333153-M15C09980017 333153-M15C09980003 333153-M15C09980016 333153-M15C09980015 333153-M15C09980014 333153-M15C09980013 333153-M15C09980004 333153-M15C09980011 333153-M15C09980010 333153-M15C09980012 333153-M15C09980008 333153-M15C09980007 333153-M15C09980006 333153-M15C09980005 333153-M15C09980002 333153-M15C09980001 333153-M15C09980009 333153-M16108850020 333153-M16108850021 333153-M16108850022 333153-M16108850023 333153-M16108850024 333153-M16108850027 333153-M16108850026 333153-M16108850028 333153-M16108850029 333153-M16108850030 333153-M16108850025 333153-M16108850019 333153-M16108850018 333153-M16108850017 333153-M16108850002 333153-M16108850003 333153-M16108850004 333153-M16108850005 333153-M16108850006 333153-M16108850007 333153-M16108850008 333153-M16108850009 333153-M16108850010 333153-M16108850011 333153-M16108850012 333153-M16108850013 333153-M16108850014 333153-M16108850015 333153-M16108850016 333153-M16108850001 333153-M16306490007 333153-M16306490006 333153-M16306490016 333153-M16306490008 333153-M16306490004 333153-M16306490003 333153-M16306490002 333153-M16306490005 333153-M16306490009 333153-M16306490018 333153-M16306490011 333153-M16306490012 333153-M16306490013 333153-M16306490015 333153-M16306490001 333153-M16306490014 333153-M16306490017 333153-M16306490010 333153-M16306490019 333153-M16306490020 333153-M16306490022 333153-M16306490043 333153-M16306490044 333153-M16306490045 333153-M16306490046 333153-M16306490047 333153-M16306490048 333153-M16306490049 333153-M16306490021 333153-M16306490050 333153-M16306490041 333153-M16306490042 333153-M16306490039 333153-M16306490023 333153-M16306490024 333153-M16306490025 333153-M16306490026 333153-M16306490027 333153-M16306490028 333153-M16306490040 333153-M16306490030 333153-M16306490029 333153-M16306490032 333153-M16306490033 333153-M16306490034 333153-M16306490035 333153-M16306490036 333153-M16306490037 333153-M16306490038 333153-M16306490031 333153-M16312490001 333153-M16312490003 333153-M16312490004 333153-M16312490005 333153-M16312490006 333153-M16312490007 333153-M16312490008 333153-M16312490009 333153-M16312490010 333153-M16312490002 333153-M16311340001 333153-M16311340002 333153-M16311340003 333153-M16311340004 333153-M16311340005 333153-M16311340006 333153-M16311340007 333153-M16311340008 333153-M16311340009 333153-M16311340010 333153-M16311340011 333153-M16311340012 333153-M16311340013 333153-M16311340014 333153-M16311340016 333153-M16311340017 333153-M16311340018 333153-M16311340019 333153-M16311340020 333153-M16311340015 333153-M16701760024 333153-M16701760025 333153-M16701760026 333153-M16701760030 333153-M16701760027 333153-M16701760028 333153-M16701760029 333153-M16701760031 333153-M16701760039 333153-M16701760033 333153-M16701760034 333153-M16701760035 333153-M16701760036 333153-M16701760037 333153-M16701760038 333153-M16701760022 333153-M16701760040 333153-M16701760032 333153-M16701760021 333153-M16701760010 333153-M16701760019 333153-M16701760001 333153-M16701760002 333153-M16701760003 333153-M16701760004 333153-M16701760005 333153-M16701760006 333153-M16701760007 333153-M16701760008 333153-M16701760009 333153-M16701760041 333153-M16701760011 333153-M16701760012 333153-M16701760013 333153-M16701760014 333153-M16701760015 333153-M16701760016 333153-M16701760017 333153-M16701760018 333153-M16701760020 333153-M16701760042 333153-M16701760044 333153-M16701760043 333153-M16701760045 333153-M16701760046 333153-M16701760047 333153-M16701760048 333153-M16701760049 333153-M16701760050 333153-M16701760023 333153-M16807530001 333153-M16807530002 333153-M16807530003 333153-M16807530005 333153-M16807530026 333153-M16807530027 333153-M16807530028 333153-M16807530029 333153-M16807530030 333153-M16807530031 333153-M16807530032 333153-M16807530033 333153-M16807530034 333153-M16807530036 333153-M16807530037 333153-M16807530038 333153-M16807530039 333153-M16807530040 333153-M16807530004 333153-M16807530025 333153-M16807530024 333153-M16807530035 333153-M16807530022 333153-M16807530023 333153-M16807530006 333153-M16807530007 333153-M16807530008 333153-M16807530010 333153-M16807530011 333153-M16807530012 333153-M16807530013 333153-M16807530009 333153-M16807530015 333153-M16807530021 333153-M16807530014 333153-M16807530019 333153-M16807530018 333153-M16807530020 333153-M16807530017 333153-M16807530016 333152-M16901950013 333152-M16901950001 333152-M16901950002 333152-M16901950003 333152-M16901950004 333152-M16901950005 333152-M16901950006 333152-M16901950007 333152-M16901950008 333152-M16901950009 333152-M16901950010 333152-M16901950011 333152-M16901950012 333152-M16901950014 333152-M16901950015 333153-M17101610006 333153-M17101610033 333153-M17101610021 333153-M17101610039 333153-M17101610038 333153-M17101610026 333153-M17101610020 333153-M17101610005 333153-M17101610022 333153-M17101610034 333153-M17101610008 333153-M17101610012 333153-M17101610007 333153-M17101610019 333153-M17101610040 333153-M17101610009 333153-M17101610018 333153-M17101610035 333153-M17101610001 333153-M17101610025 333153-M17101610011 333153-M17101610003 333153-M17101610023 333153-M17101610015 333153-M17101610014 333153-M17101610002 333153-M17101610036 333153-M17101610031 333153-M17101610017 333153-M17101610032 333153-M17101610037 333153-M17101610013 333153-M17101610027 333153-M17101610028 333153-M17101610029 333153-M17101610030 333153-M17101610024 333153-M17101610016 333153-M17101610010 333153-M17101610004 333152-M17305500001 333152-M17305500007 333152-M17305500003 333152-M17305500002 333152-M17305500006 333152-M17305500005 333152-M17305500009 333152-M17305500008 333152-M17305500010 333152-M17305500004 333153-M17400810004 333153-M17400810005 333153-M17400810013 333153-M17400810011 333153-M17400810006 333153-M17400810015 333153-M1740081

Distribution pattern

Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.

device · product 7 of 16

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The V series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP(respiration), CO2, IBP, C.O. and AG(anesthetic gas), RM(respiratory mechanics), BIS(bispectral index) and ICG(impedance cardiography). Component: No

Z-1146-2026

Recall number: Z-1146-2026
Initiated: October 24, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Edan Diagnostics
Quantity: 342

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Code information

EDAN Model: elite V8 UDI-DI code: 06944413801707 Serial/Lot Numbers: 260342-M17B09290001 002338-M23226990001 002338-M23226990002 002338-M23226990004 002338-M23226990003 002338-M23812870001 002338-M23C15870001 002338-M24A12130001 260342-M16506570001 260342-M15A03180001 002338-K22100150003 002338-K22100150004 002338-K22100150002 002338-K22100150001 261241-M22701020001 002338-M25705810020 002338-M25705810021 002338-M25705810011 002338-M25705810003 002338-M25705810013 002338-M25705810029 002338-M25705810033 002338-M25705810001 002338-M25705810010 002338-M25705810009 002338-M25705810004 002338-M25705810012 002338-M25705810018 002338-M25705810032 002338-M25705810017 002338-M25705810019 002338-M25705810024 002338-M25705810030 002338-M25705810031 002338-M25705810025 002338-M25705810016 002338-M25705810008 002338-M25705810006 002338-M25705810002 002338-M25705810028 002338-M25705810027 002338-M25705810022 002338-M25705810026 002338-M25705810023 002338-M25705810015 002338-M25705810014 002338-M25705810005 002338-M25705810007 002338-M25908680004 002338-M25908680003 002338-M25908680002 002338-M25908680001 EDAN Model: elite V5 UDI-DI code: 06944413802155 Serial/Lot Numbers: 260586-M17211520002 260586-M17211520006 260586-M17211520004 260586-M17211520008 260586-M17211520001 260586-M17211520009 260586-M17211520007 260586-M17211520003 260586-M17211520010 260586-M17211520005 260588-M17902120009 260588-M17902120002 260588-M17902120008 260588-M17902120001 260588-M17902120003 260588-M17902120006 260588-M17902120007 260588-M17902120004 260588-M17902120005 260588-M17902120010 260586-M19413090016 260586-M19413090007 260586-M19413090017 260586-M19413090006 260586-M19413090010 260586-M19413090014 260586-M19413090011 260586-M19413090008 260586-M19413090004 260586-M19413090019 260586-M19413090012 260586-M19413090003 260586-M19413090013 260586-M19413090009 260586-M19413090005 260586-M19413090002 260586-M19413090018 260586-M19413090001 260586-M19413090020 260586-M19413090015 260586-M19507110023 260586-M19507110013 260586-M19507110005 260586-M19507110009 260586-M19507110004 260586-M19507110019 260586-M19507110018 260586-M19507110024 260586-M19507110003 260586-M19507110008 260586-M19507110020 260586-M19507110014 260586-M19507110001 260586-M19507110002 260586-M19507110016 260586-M19507110010 260586-M19507110011 260586-M19507110012 260586-M19507110015 260586-M19507110021 260586-M19507110022 260586-M19507110007 260586-M19507110006 260586-M19507110025 260586-M19507110017 260586-M19604520007 260586-M19604520005 260586-M19604520006 260586-M19604520008 260586-M19604520001 260586-M19604520011 260586-M19604520010 260586-M19604520003 260586-M19604520009 260586-M19604520002 260586-M19604520004 260586-M19701080013 260586-M19702060010 260586-M19702060002 260586-M19702060003 260586-M19702060006 260586-M19702060013 260586-M19702060014 260586-M19701080004 260586-M19701080010 260586-M19701080011 260586-M19701080018 260586-M19701080003 260586-M19702060004 260586-M19701080007 260586-M19702060007 260586-M19701080008 260586-M19701080005 260586-M19701080009 260586-M19702060005 260586-M19702060015 260586-M19701080002 260586-M19701080019 260586-M19701080012 260586-M19702060001 260586-M19702060011 260586-M19701080020 260586-M19702060008 260586-M19701080014 260586-M19701080016 260586-M19702060009 260586-M19702060012 260586-M19701080001 260586-M19701080015 260586-M19701080006 260586-M19701080017 260586-M19805320026 260586-M19805320038 260586-M19805320024 260586-M19805320014 260586-M19805320001 260586-M19805320055 260586-M19805320046 260586-M19805320045 260586-M19805320054 260586-M19805320015 260586-M19805320023 260586-M19805320020 260586-M19805320016 260586-M19805320004 260586-M19805320008 260586-M19805320053 260586-M19805320050 260586-M19805320002 260586-M19805320048 260586-M19805320025 260586-M19805320009 260586-M19805320011 260586-M19805320027 260586-M19805320043 260586-M19805320052 260586-M19805320051 260586-M19805320041 260586-M19805320031 260586-M19805320029 260586-M19805320022 260586-M19805320021 260586-M19805320019 260586-M19805320012 260586-M19805320049 260586-M19805320042 260586-M19805320039 260586-M19805320032 260586-M19805320006 260586-M19805320005 260586-M19805320003 260586-M19805320044 260586-M19805320034 260586-M19805320017 260586-M19805320040 260586-M19805320035 260586-M19805320036 260586-M19805320033 260586-M19805320030 260586-M19805320028 260586-M19805320018 260586-M19805320013 260586-M19805320007 260586-M19805320047 260586-M19805320010 260586-M19805320037 260586-M20B07060008 260586-M20B07060005 260586-M20B07060007 260586-M20B07060010 260586-M20B07060001 260586-M20B07060006 260586-M20B07060011 260586-M20B07060003 260586-M20B07060009 260586-M20B07060004 260586-M20B07060012 260586-M20B07060002 260586-M20B10740014 260586-M20B10740008 260586-M20B10740015 260586-M20B10740005 260586-M20B10740004 260586-M20B10740007 260586-M20B10740012 260586-M20B10740001 260586-M20B10740003 260586-M20B10740013 260586-M20B10740009 260586-M20B10740011 260586-M20B10740006 260586-M20B10740010 260586-M20B10740002 260586-M20B17820010 260586-M20B17820001 260586-M20B17820003 260586-M20B17820008 260586-M20B17820005 260586-M20B17820004 260586-M20B17820002 260586-M20B17820007 260586-M20B17820009 260586-M20B17820006 260586-M21C04150002 260586-M21C04150004 260586-M21C04150005 260586-M21C04150009 260586-M21C04150008 260586-M21C04150010 260586-M21C04150006 260586-M21C04150003 260586-M21C04150001 260586-M21C04150007 260586-M22102050013 260586-M22102050004 260586-M22102050008 260586-M22102050006 260586-M22102050001 260586-M22102050015 260586-M22102050005 260586-M22102050014 260586-M22102050007 260586-M22102050002 260586-M22102050012 260586-M22102050009 260586-M22102050010 260586-M22102050003 260586-M22102050011 260586-M22804770008 260586-M22804770011 260586-M22804770010 260586-M22804770005 260586-M22804770004 260586-M22804770012 260586-M22804770002 260586-M22804770001 260586-M22804770009 260586-M22804770003 260586-M22804770006 260586-M22804770007 260586-M23515110001 260586-M23515110010 260586-M23515110009 260586-M23515110003 260586-M23515110008 260586-M23515110007 260586-M23515110002 260586-M23515110006 260586-M23515110004 260586-M23515110005 260586-M24119070001 260586-M24119070003 260586-M24119070004 260586-M24119070002 260586-M24408410002 260586-M24408410001 260586-M24610240005 260586-M24610240002 260586-M24610240004 260586-M24610240001 260586-M24610240003 260586-M21308230001 260586-M21816190003 260586-M21816190001 260586-M21816190002 260586-M21816190004 260586-M21816190005 260586-M21816190006 260586-M21C13880002 260586-M21C13880001 260586-M22410650002 260586-M22410650001 260586-M22A01240001 260586-M22A01240002 EDAN Model: elite V6 UDI-DI code: 06944413802162 Serial/Lot Numbers: 260598-M17409030001 260597-M18402870001 260597-M23613650001 260598-M17207680001 260597-M17211510002 260597-M17211510001 260597-M20B20220001 260597-M23515100001 260597-M24803380006 260597-M24803380005 260597-M24803380002 260597-M24803380001 260597-M24803380004 260597-M24803380003 260597-M21816200001 260597-M25315990001

Distribution pattern

Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.

device · product 8 of 16

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring of multiple physiological parameters, including ECG, respiration (RESP), non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), temperature (TEMP), invasive pressure (IBP), Carbon Dioxide (CO2). The system capabilities include storing, displaying, analyzing and controlling such data afterwards. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. The system is intended to be used during patient transport inside and outside of the hospital environment. Component: No

Z-1147-2026

Recall number: Z-1147-2026
Initiated: October 24, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Edan Diagnostics
Quantity: 377

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Code information

EDAN Model: iM20 UDI-DI code: 06944413802179 Serial/Lot Numbers: 260502-M17A03230001 260374-M18401280001 260374-M18401280002 260374-M18407120001 260374-M18407120002 260374-M18613240001 260374-M18613240002 260374-M18A08010001 260374-M20506470001 260374-M20506470003 260374-M20506470005 260374-M20506470002 260374-M20506470004 260374-M18402820001 260374-M20B06690002 260374-M20B06690003 260374-M20B06690001 260374-M20C13130002 260374-M20C13130004 260374-M20C13130001 260374-M20C13130003 260374-M20C13130005 260374-M21108520006 260374-M21108520015 260374-M21108520009 260374-M21108520004 260374-M21108520001 260374-M21108520014 260374-M21108520011 260374-M21108520007 260374-M21108520002 260374-M21108520005 260374-M21108520003 260374-M21108520010 260374-M21108520012 260374-M21108520013 260374-M21108520008 260374-M21608850002 260374-M21616970003 260374-M21608850001 260374-M21608850005 260374-M21608850004 260374-M21616970002 260374-M21608850003 260374-M21616970001 260374-K21800220002 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260374-M23B14130012 260374-M23B14130001 260374-M23B14130014 260374-M23B14130010 260374-M23B14130009 260374-M23B14130002 260374-M23B14130018 260374-M23B14130007 260374-M23B14130005 260374-M23B14130024 260374-M23B14130006 260374-M23B14130026 260374-M23B14130016 260374-M23B14130004 260374-M23B14130015 260374-M23B14130017 260374-M23B14130023 260374-M23C11330001 260374-M23C11330009 260374-M23C11330007 260374-M23C11330008 260374-M23C11330005 260374-M23C11330004 260374-M23C11330003 260374-M23C11330010 260374-M23C11330006 260374-M23C11330002 260374-M23C18730005 260374-M23C18730002 260374-M23C18730001 260374-M23C18730004 260374-M23C18730003 260374-M24118900004 260374-M24118900005 260374-M24118900003 260374-M24118900001 260374-M24118900002 260374-M24803340005 260374-M24803340002 260374-M24803340006 260374-M24803340003 260374-M24803340001 260374-M24803340004 262244-M22701050001 260374-M25216280003 260374-M25216280002 260374-M25216280001 260374-M25312790001 260374-M25309570001 260374-M25312790002 260374-M25520360002 260374-M25520360004 260374-M25520360003 260374-M25520360005 260374-M25520360001 260374-M25709700004 260374-M25709700005 260374-M25709700001 260374-M25709700003 260374-M25709700002 260374-M25906630001 260374-M25904250004 260374-M25904250008 260374-M25904250009 260374-M25904250002 260374-M25904250005 260374-M25901780001 260374-M25901780006 260374-M25901780007 260374-M25901780004 260374-M25901780008 260374-M25904250001 260374-M25901780002 260374-M25904250003 260374-M25904250010 260374-M25901780005 260374-M25904250006 260374-M25901780003 260374-M25904250011 260374-M25904250012 260374-M25904250007

Distribution pattern

Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.

device · product 9 of 16

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. Component: No

Z-1148-2026

Recall number: Z-1148-2026
Initiated: October 24, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Edan Diagnostics
Quantity: 3824

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Code information

EDAN Model: X8 UDI-DI code: 06944413810907 Serial/Lot Numbers: 261586-M21116620010 261586-M21116620002 261586-M21116620007 261586-M21116620006 261586-M21116620009 261586-M21116630001 261586-M21116620008 261586-M21116620003 261586-M21116630005 261586-M21116630003 261586-M21116620004 261586-M21116620001 261586-M21116630004 261586-M21116630002 261586-M21116620005 261586-M21301970003 261586-M21301970004 261586-M21301960001 261586-M21301970005 261586-M21301960003 261586-M21301970002 261586-M21301970001 261586-M21301960002 261586-M21714500002 261586-M21714500001 261586-M21714500003 261586-M21816750005 261586-M21816750003 261586-M21816750002 261586-M21816750004 261586-M21816750001 261586-M22105750001 261586-M22105750007 261586-M22105750008 261586-M22105750010 261586-M22105750002 261586-M22105750005 261586-M22105750009 261586-M22105750006 261586-M22105750003 261586-M22105750004 261586-M22405430007 261586-M22405430001 261586-M22405430004 261586-M22405430010 261586-M22405430006 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261590-M22B07360019 261590-M22B07360021 261590-M22B07360013 261590-M22B07360014 261590-M22B07360016 261590-M22B07360031 261590-M22B07360047 261590-M22B07360048 261590-M22B07360037 261590-M22B07360025 261590-M23222350007 261590-M23222350017 261590-M23222350023 261590-M23222350035 261590-M23222350029 261590-M23222350028 261590-M23222350019 261590-M23222350018 261590-M23222350009 261590-M23222350008 261590-M23222350014 261590-M23222350032 261590-M23222350031 261590-M23222350030 261590-M23222350004 261590-M23222350025 261590-M23222350033 261590-M23222350026 261590-M23222350024 261590-M23222350016 261590-M23222350039 261590-M23222350038 261590-M23222350015 261590-M23222350005 261590-M23222350037 261590-M23222350022 261590-M23222350021 261590-M23222350020 261590-M23222350040 261590-M23222350012 261590-M23222350011 261590-M23222350010 261590-M23222350002 261590-M23222350001 261590-M23222350036 261590-M23222350034 261590-M23222350027 261590-M23222350013 261590-M23222350006 261590-M23222350003 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Distribution pattern

Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.

device · product 10 of 16

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. Component: No

Z-1149-2026

Recall number: Z-1149-2026
Initiated: October 24, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Edan Diagnostics
Quantity: 379

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Code information

EDAN Model: iX10 UDI-DI code: 06944413815889 Serial/Lot Numbers: 262541-M24816120001 262541-M24A09820001 262541-M24B06240003 262541-M24B06240002 262541-M24B06240001 262541-M25110410016 262541-M25110420014 262541-M25110420008 262541-M25110420009 262541-M25110420024 262541-M25110420023 262541-M25110420025 262541-M25110420018 262541-M25110410001 262541-M25110410009 262541-M25110410003 262541-M25110410004 262541-M25110410011 262541-M25110410015 262541-M25110410020 262541-M25110410002 262541-M25110410012 262541-M25110410005 262541-M25110410013 262541-M25110410014 262541-M25110410007 262541-M25110410008 262541-M25110410017 262541-M25110410018 262541-M25110410019 262541-M25110410010 262541-M25110420011 262541-M25110410006 262541-M25110420007 262541-M25110420020 262541-M25110420013 262541-M25110420001 262541-M25110420019 262541-M25110420022 262541-M25110420003 262541-M25110420010 262541-M25110420015 262541-M25110420004 262541-M25110420016 262541-M25110420012 262541-M25110420005 262541-M25110420017 262541-M25110420021 262541-M25110420006 262541-M25110420002 269944-M25514090006 269944-M25514090002 269944-M25514090004 269944-M25514090008 269944-M25514090007 269944-M25514090001 269965-M25510270004 269965-M25510270003 269965-M25510270001 269944-M25514090009 269944-M25514090005 269944-M25514090010 269965-M25510270002 269965-M25510270005 269944-M25514090003 262541-M25514080006 262541-M25510240004 262541-M25510240010 262541-M25514080005 262541-M25514080004 262541-M25514080002 262541-M25514080013 262541-M25514080003 262541-M25510240012 262541-M25510240001 262541-M25510240008 262541-M25510240015 262541-M25510240006 262541-M25510240009 262541-M25514080008 262541-M25510240011 262541-M25514080012 262541-M25510240007 262541-M25510240002 262541-M25510240003 262541-M25514080009 262541-M25510240005 262541-M25514080011 262541-M25514080007 262541-M25514080001 262541-M25510240013 262541-M25510240014 262541-M25514080010 262541-M25510240016 262541-M25704070016 262541-M25704070008 262541-M25704060002 262541-M25704060013 262541-M25704070011 262541-M25704070010 262541-M25704070003 262541-M25704070002 262541-M25704070009 262541-M25704070007 262541-M25704070005 262541-M25704070001 262541-M25704060018 262541-M25704060024 262541-M25704060014 262541-M25704070020 262541-M25704070018 262541-M25704070023 262541-M25704070022 262541-M25704070021 262541-M25704070019 262541-M25704070013 262541-M25704070006 262541-M25704070004 262541-M25704070012 262541-M25704060006 262541-M25704060005 262541-M25704060010 262541-M25704060020 262541-M25704060023 262541-M25704060021 262541-M25704060009 262541-M25704070015 262541-M25704070017 262541-M25704070025 262541-M25704060004 262541-M25704060008 262541-M25704060012 262541-M25704060016 262541-M25704060022 262541-M25704060001 262541-M25704060007 262541-M25704060011 262541-M25704060017 262541-M25704060019 262541-M25704070014 262541-M25704070024 262541-M25704060003 262541-M25704060015 262541-M25704060025 EDAN Model: iX12 UDI-DI code: 06944413815896 Serial/Lot Numbers: 262542-M23808800001 262542-M24B06270001 262542-M24B06280001 262542-M24B06250001 262542-M24B06280002 262542-M24B06270002 262542-M24B06260001 262542-M24B06250002 262542-M25110440008 262542-M25110430024 262542-M25110430020 262542-M25110430009 262542-M25110430006 262542-M25110430001 262542-M25110440016 262542-M25110440010 262542-M25110440005 262542-M25110440003 262542-M25110440001 262542-M25110430021 262542-M25110430013 262542-M25110430007 262542-M25110440011 262542-M25110430003 262542-M25110440017 262542-M25110440015 262542-M25110440020 262542-M25110430005 262542-M25110430010 262542-M25110430012 262542-M25110430014 262542-M25110430018 262542-M25110440007 262542-M25110430011 262542-M25110430016 262542-M25110430017 262542-M25110440013 262542-M25110440018 262542-M25110430019 262542-M25110440019 262542-M25110440014 262542-M25110440006 262542-M25110430023 262542-M25110430015 262542-M25110430002 262542-M25110430022 262542-M25110440012 262542-M25110430004 262542-M25110440009 262542-M25110440004 262542-M25110440002 262542-M25110430025 262542-M25110430008 269943-M25514100009 269943-M25514100033 269963-M25510300013 269943-M25514100030 269943-M25514100031 269963-M25510300011 269963-M25510300026 269963-M25510300008 269943-M25514100040 269943-M25514100027 269943-M25514100005 269963-M25510300030 269963-M25510300005 269943-M25514100015 269963-M25510300029 269943-M25514100032 269943-M25514100037 269963-M25510300025 269963-M25510300028 269943-M25514100038 269963-M25510300012 269943-M25514100039 269943-M25514100034 269943-M25514100028 269963-M25510300003 269963-M25510300010 269963-M25510300014 269943-M25514100026 269963-M25510300002 269943-M25514100021 269943-M25514100001 269963-M25510300018 269943-M25514100003 269963-M25510300021 269963-M25510300016 269963-M25510300009 269943-M25514100020 269963-M25510300019 269943-M25514100012 269963-M25510300004 269943-M25514100035 269943-M25514100014 269963-M25510300017 269963-M25510300001 269963-M25510300023 269963-M25510300022 269963-M25510300007 269943-M25514100019 269943-M25514100007 269943-M25514100025 269943-M25514100013 269963-M25510300027 269963-M25510300015 269963-M25510300006 269943-M25514100029 269943-M25514100024 269943-M25514100022 269943-M25514100017 269943-M25514100004 269943-M25514100002 269943-M25514100008 269943-M25514100018 269943-M25514100006 269943-M25514100010 269943-M25514100011 269963-M25510300024 269963-M25510300020 269943-M25514100036 269943-M25514100023 269943-M25514100016 262542-M25510290001 262542-M25510280012 262542-M25510280015 262542-M25510280010 262542-M25510280011 262542-M25510290012 262542-M25510290005 262542-M25510290003 262542-M25510290002 262542-M25510280007 262542-M25510280005 262542-M25510290007 262542-M25510290006 262542-M25510280016 262542-M25510280004 262542-M25510280003 262542-M25510290011 262542-M25510290009 262542-M25510290010 262542-M25510280001 262542-M25510280002 262542-M25510280008 262542-M25510280009 262542-M25510280014 262542-M25510290013 262542-M25510280006 262542-M25510290008 262542-M25510290004 262542-M25510280013 262542-M25704090002 262542-M25704090015 262542-M25704090017 262542-M25704090004 262542-M25704090009 262542-M25704090024 262542-M25704090021 262542-M25704090014 262542-M25704090025 262542-M25704090007 262542-M25704090008 262542-M25704090003 262542-M25704090001 262542-M25704090019 262542-M25704090023 262542-M25704090011 262542-M25704090020 262542-M25704090010 262542-M25704090005 262542-M25704080020 262542-M25704090022 262542-M25704090012 262542-M25704090013 262542-M25704090016 262542-M25704090006 262542-M25704080009 262542-M25704080016 262542-M25704080018 262542-M25704080022 262542-M25704080008 262542-M25704080010 262542-M25704090018 262542-M25704080014 262542-M25704080012 262542-M25704080002 262542-M25704080015 262542-M25704080017 262542-M25704080023 262542-M25704080005 262542-M25704080004 262542-M25704080007 262542-M25704080021 262542-M25704080006 262542-M25704080001 262542-M25704080011 262542-M25704080024 262542-M25704080003 262542-M25704080025 262542-M25704080019 262542-M25704080013 EDAN Model: iX15 UDI-DI code: 06944413815902 Serial/Lot Numbers: 262543-M24B06290002 262543-M24B06290001 262543-M25110450003 262543-M25110450002 262543-M25110450001 262543-M25110450004 262543-M25110450005 262543-M25303610001 269961-M25510320004 269961-M25510320002 269961-M25510320010 269942-M25514110006 269961-M25510320008 269961-M25510320005 269961-M25510320011 269942-M25514110001 269942-M25514110003 269961-M25510320012 269961-M25510320013 269942-M25514110010 269961-M25510320009 269961-M25510320006 269961-M25510320001 269942-M25514110007 269942-M25514110008 269961-M25510320015 269961-M25510320003 269942-M25514110005 269961-M25510320014 269961-M25510320007 269942-M25514110004 269942-M25514110002 269942-M25514110009

Distribution pattern

Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.

device · product 11 of 16

Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring information from the medical devices. All these collected information can be displayed, printed, alarmed and recorded. Component: No

Z-1150-2026

Recall number: Z-1150-2026
Initiated: October 24, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Edan Diagnostics
Quantity: 195

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Code information

EDAN Model: MFM-CMS UDI-DI code: 06944413800229 Serial/Lot Numbers: 261432-M18312480001 261432-M18803430001 261432-M18B04070001 261432-M18B04070002 261432-M18C06730001 261432-M18C06730002 261432-M18C06730004 261432-M18C06730003 261432-M18C06730005 261432-M18C06730006 261432-M19402160001 261432-M19402160003 261432-M19402160002 261432-M19B02530001 261432-M19B02530006 261432-M19A10370007 261432-M19B02530005 261432-M19B02530003 261432-M19B02530002 261432-M20213550006 261432-M20213550005 261432-M20213550003 261432-M20213550002 261432-M20213550004 261432-M20213550001 261432-M20702060001 261432-M20702060006 261432-M20702060002 261432-M20702060004 261432-M20702060007 261432-M20702060005 261432-M20708340003 261432-M20708340005 261432-M20708340002 261432-M20708340004 261432-M20708340001 261432-M20708340006 261432-M20810650003 261432-M20810650004 261432-M20810650002 261432-M20810650001 261432-M20810650006 261432-M20810650005 261432-M18401960001 261432-M20C04930001 261432-M20C04930002 261432-M20C04930005 261432-M20C04930004 261432-M20C04930003 261432-M20C04930006 261432-M21111490005 261432-M21111490004 261432-M21111490003 261432-M21111490002 261432-M21111490006 261432-M21111490001 261432-M21206490002 261432-M21206490006 261432-M21206490001 261432-M21206490005 261432-M21206490004 261432-M21206490003 261432-M21409870005 261432-M21409870003 261432-M21409870004 261432-M21409870001 261432-M21409870002 261432-M21409870006 261432-M21509140001 261432-M21509140003 261432-M21509140005 261432-M21509140004 261432-M21509140006 261432-M21509140002 261432-M21706970007 261432-M21706970008 261432-M21706970005 261432-M21706970001 261432-M21706970004 261432-M21706970006 261432-M21809930002 261432-M21909020003 261432-M21909020004 261432-M21909020002 261432-M21810820020 261432-M21810820006 261432-M21810820003 261432-M21809930005 261432-M21809930004 261432-M21809930003 261432-M21809930001 261432-M21909020001 261432-M18400410002 261432-M18310890001 261432-M18501600001 261432-M18802330001 261432-M19912390001 261432-M20412240001 261432-M20708340007 261432-M20915430001 261432-M20B09110001 261432-M20B13840001 261432-M20C10170001 261432-M21204410002 261432-M21204410003 261432-M21204410004 261432-M21204410001 261432-M21306400002 261432-M21306400003 261432-M21306400001 261432-M21316340001 261432-M21404840001 261432-M21512920002 261432-M21512920001 261432-M21615470001 261432-M21702760001 114M2330484 114M2330484 114M2330484 114M2330484 114M2330484 114M2330484 114M2330484 114M2370760 114M2370760 114M2370760 114M2370760 114M2370760 114M2370760 114M2370760 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1625 267M23B1625 267M23B1625 267M23B1625 267M23B1625 267M23B1625 267M23B1625 114M23B0232 114M23B0232 114M23B0232 114M23B0232 114M23B0232 114M23B0232 114M23B0232 114M23B0232 EDAN Model: MFM-CMS UDI-DI code: 06944413814264 Serial/Lot Numbers: 262237-M24611330012 262237-M24611330001 262237-M24611330011 262237-M24611330014 262237-M24611330009 262237-M24611330019 262237-M24611330004 262237-M24611330008 262237-M24611330007 262237-M24611330017 262237-M24611330010 262237-M24611330003 262237-M24611330005 262237-M24611330015 262237-M24611330013 262237-M24611330018 262237-M24611330002 262237-M24611330006 262237-M24611330016 262237-M24814380001 262237-M24905030001 262237-M24C17400001 262237-M24C17400003 262237-M24C17400004 262237-M24C17400002 262237-M24C17400005 MRM-CMSIII 262237-M24B06940008 262237-M24B06940001 262237-M24B06940003 262237-M24B06940005 262237-M24B06940010 262237-M24B06940004 262237-M24B06940007 262237-M24B06940006 262237-M24B06940002 262237-M24B06940009

Distribution pattern

Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.

device · product 12 of 16

Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activity, and the MFM-CNS additional monitors maternal vital signs. Data are automatically acquired from bedside monitors, for the purpose of collecting. processing and saving the patient and/or clinical data that is normally provided on record papers and/or separate bedside monitors. They provide electronic medical records and operate with off-the-shelf software and hardware. Component: No

Z-1151-2026

Recall number: Z-1151-2026
Initiated: October 24, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Edan Diagnostics
Quantity: 395

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Code information

EDAN Model: MFM-CNS UDI-DI code: 06944413800236 Serial/Lot Numbers: 460793-M18C12290001 460793-M19109170001 460793-M19200240001 460793-M19411950001 460793-M19804210001 460793-M19912750001 460793-M19B07530001 460793-M20809190001 460793-M20913190002 460793-M20913190001 460793-M20B19040001 460793-M21600070001 460793-M21603510001 460793-M24702870002 460793-M24702870001 460793-M25203640001 460793-M25314460001 460793-M25314460002 460793-M25610650001 460793-M25610650003 460793-M25610650002 EDAN Model: MFM-CNS Lite UDI-DI code: 06944413807983 Serial/Lot Numbers: 460570-M19710380001 460570-M19710370001 460570-M19A06460005 460570-M19A06460006 460570-M19A06460007 460570-M19A06460015 460570-M19A06460008 460570-M19A06460009 460570-M19A06460001 460570-M19A06460011 460570-M19A06460003 460570-M19A06460004 460570-M19A06460010 460570-M19A06460002 460570-M19A06460012 460570-M19A06460013 460570-M19A06460014 460570-M20602690001 460570-M20602690003 460570-M20602690002 460570-M20700020009 460570-M20700020002 460570-M20700020011 460570-M20700020012 460570-M20700020005 460570-M20700020007 460570-M20700020013 460570-M20700020008 460570-M20700020003 460570-M20700020004 460570-M20700020001 460570-M20700020010 460570-M20700020006 460570-M20807880003 460570-M20807880005 460570-M20807880001 460570-M20807880002 460570-M20807880004 460570-M20A08380001 460570-M20A08380004 460570-M20A08380005 460570-M20A08380002 460570-M20A08380003 460570-M20C16310008 460570-M20C16310009 460570-M20C16310010 460570-M20C16310004 460570-M20C16310006 460570-M20C16310001 460570-M20C16310002 460570-M20C16310003 460570-M20C16310005 460570-M20C16310007 460570-M24814460001 460570-M24814460002 460570-M24814460004 460570-M24814460003 460570-M24814460005 460570-M24B06920003 460570-M24B06920001 460570-M24B06920004 460570-M24B06920002 460570-M24B06920005 460570-M25216230002 460570-M25216230004 460570-M25216230005 460570-M25216230001 460570-M25216230006 460570-M25407560001 460570-M25407560002 460570-M25511390003 460570-M25511390001 460570-M25511390004 460570-M25511390002 461334-M25321000004 461334-M25321000008 461334-M25321000014 461334-M25321000019 461334-M25321000022 461334-M25321000034 461334-M25321000039 461334-M25321000055 461334-M25321000068 461334-M25321000070 461334-M25321000077 461334-M25321000090 461334-M25321000097 461335-M25320990002 461335-M25320990026 461335-M25320990051 461335-M25320990062 461335-M25320990068 461335-M25320990070 461335-M25320990074 461335-M25320990077 461335-M25320990086 461335-M25320990090 461335-M25320990092 461335-M25320990098 461335-M25320990108 461335-M25320990121 461335-M25320990132 461335-M25320990136 461335-M25320990138 461335-M25320990139 461335-M25320990152 461335-M25320990156 461335-M25320990157 461335-M25320990159 461335-M25320990181 461334-M25321000015 461334-M25321000029 461334-M25321000035 461334-M25321000044 461334-M25321000049 461334-M25321000053 461334-M25321000056 461334-M25321000060 461334-M25321000067 461334-M25321000075 461334-M25321000083 461334-M25321000087 461334-M25321000098 461335-M25320990003 461334-M25321000007 461334-M25321000010 461334-M25321000017 461334-M25321000024 461334-M25321000028 461334-M25321000030 461334-M25321000037 461335-M25320990007 461335-M25320990009 461335-M25320990011 461335-M25320990034 461335-M25320990037 461335-M25320990039 461335-M25320990041 461334-M25321000048 461334-M25321000051 461334-M25321000052 461334-M25321000063 461334-M25321000066 461334-M25321000074 461334-M25321000078 461335-M25320990050 461335-M25320990054 461335-M25320990058 461335-M25320990063 461335-M25320990065 461335-M25320990069 461335-M25320990076 461334-M25321000080 461334-M25321000094 461334-M25321000099 461334-M25321000100 461335-M25320990004 461335-M25320990008 461335-M25320990030 461335-M25320990093 461335-M25320990095 461335-M25320990099 461335-M25320990117 461335-M25320990123 461335-M25320990147 461335-M25320990160 461335-M25320990171 461335-M25320990175 461335-M25320990183 461335-M25320990190 461335-M25320990032 461335-M25320990038 461335-M25320990052 461335-M25320990066 461335-M25320990081 461335-M25320990096 461335-M25320990113 461335-M25320990114 461335-M25320990124 461335-M25320990143 461335-M25320990144 461335-M25320990158 461335-M25320990161 461335-M25320990165 461335-M25320990187 461335-M25320990191 461335-M25320990195 461334-M25321000005 461334-M25321000018 461334-M25321000038 461334-M25321000050 461334-M25321000057 461334-M25321000065 461334-M25321000081 461334-M25321000082 461334-M25321000086 461334-M25321000095 461335-M25320990001 461335-M25320990016 461335-M25320990023 461335-M25320990025 461335-M25320990031 461335-M25320990046 461335-M25320990060 461335-M25320990064 461335-M25320990067 461335-M25320990073 461335-M25320990075 461335-M25320990079 461335-M25320990094 461335-M25320990097 461335-M25320990102 461335-M25320990106 461335-M25320990107 461335-M25320990109 461335-M25320990111 461335-M25320990115 461335-M25320990120 461335-M25320990125 461335-M25320990137 461335-M25320990141 461335-M25320990145 461335-M25320990170 461335-M25320990184 461334-M25321000002 461334-M25321000011 461334-M25321000012 461334-M25321000031 461334-M25321000032 461334-M25321000040 461334-M25321000047 461334-M25321000084 461334-M25321000088 461335-M25320990005 461335-M25320990021 461335-M25320990033 461335-M25320990035 461334-M25321000001 461334-M25321000003 461334-M25321000006 461334-M25321000013 461334-M25321000016 461334-M25321000025 461334-M25321000033 461334-M25321000036 461334-M25321000045 461334-M25321000061 461334-M25321000062 461334-M25321000079 461334-M25321000085 461335-M25320990006 461335-M25320990010 461335-M25320990012 461335-M25320990018 461335-M25320990036 461335-M25320990053 461335-M25320990057 461335-M25320990059 461335-M25320990071 461335-M25320990080 461335-M25320990084 461335-M25320990088 461335-M25320990100 461335-M25320990105 461335-M25320990112 461335-M25320990116 461335-M25320990118 461335-M25320990119 461335-M25320990127 461335-M25320990040 461335-M25320990042 461335-M25320990048 461335-M25320990055 461335-M25320990082 461335-M25320990101 461335-M25320990122 461335-M25320990126 461335-M25320990128 461335-M25320990129 461335-M25320990131 461335-M25320990150 461335-M25320990155 461335-M25320990173 461335-M25320990174 461335-M25320990182 461335-M25320990186 461335-M25320990188 461335-M25320990189 461335-M25320990130 461335-M25320990135 461335-M25320990142 461335-M25320990146 461335-M25320990148 461335-M25320990149 461335-M25320990163 461335-M25320990164 461335-M25320990177 461335-M25320990193 461335-M25320990194 461334-M25321000020 461334-M25321000023 461334-M25321000027 461334-M25321000043 461334-M25321000054 461334-M25321000059 461334-M25321000072 461334-M25321000089 461334-M25321000091 461334-M25321000092 461335-M25320990013 461335-M25320990015 461335-M25320990019 461335-M25320990024 461335-M25320990027 461335-M25320990029 461335-M25320990043 461335-M25320990045 461335-M25320990049 461335-M25320990061 461335-M25320990087 461335-M25320990089 461335-M25320990091 461335-M25320990110 461335-M25320990133 461335-M25320990140 461335-M25320990153 461335-M25320990154 461335-M25320990167 461335-M25320990172 461335-M25320990176 461335-M25320990178 461335-M25320990179 461335-M25320990197 461334-M25321000009 461334-M25321000021 461334-M25321000026 461334-M25321000041 461334-M25321000042 461334-M25321000046 461334-M25321000058 461334-M25321000064 461334-M25321000069 461334-M25321000071 461334-M25321000073 461334-M25321000076 461334-M25321000093 461334-M25321000096 461335-M25320990014 461335-M25320990017 461335-M25320990020 461335-M25320990022 461335-M25320990028 461335-M25320990044 461335-M25320990047 461335-M25320990056 461335-M25320990072 461335-M25320990078 461335-M25320990083 461335-M25320990085 461335-M25320990103 461335-M25320990104 461335-M25320990134 461335-M25320990151 461335-M25320990162 461335-M25320990166 461335-M25320990168 461335-M25320990169 461335-M25320990180 461335-M25320990185 461335-M25320990192 461335-M25320990196 461335-M25320990198 461335-M25320990199 461335-M25320990200

Distribution pattern

Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.

device · product 13 of 16

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rate and CO2 in a hospital, hospital type facilities environment and intra-hospital moves. Component: No

Z-1152-2026

Recall number: Z-1152-2026
Initiated: October 24, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Edan Diagnostics
Quantity: 354

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Code information

EDAN Model: M3B UDI-DI code: 06944413800625 Serial/Lot Numbers: 302135-M16304900001 302135-M16304900002 261184-K17400190004 261184-K17400190001 261184-K17400190006 261184-K17400190002 261184-K17400190005 261184-K17400190003 261184-M17A03040001 261184-M18502370001 360126-M18810390001 360126-M18A08360001 360126-M18B13740001 360126-M19302070001 360126-M19302070002 360126-M19302070004 360126-M19302070003 360126-M20310110001 360126-M20310110002 360126-M20507230004 360126-M20507230003 360126-M20507230002 360126-M20507230001 360126-M20507230010 360126-M20507230007 360126-M20507230006 360126-M20507230008 360126-M20507230009 360126-M20507230005 360126-M23226940004 360126-M23226940005 360126-M23226940003 360126-M23226940001 360126-M23226940002 360126-M24511420002 360126-M24511420001 360126-M24716380001 360126-M24716380002 360126-M24716380003 360126-M24716380004 360126-M24716380005 302135-M16403060001 302135-M16403060002 302135-M16403060003 302135-M16403060004 302135-M16901880001 302135-M16901880002 302135-M16901880003 360126-M19805440001 360126-M19805440002 360126-M19805440003 360126-M19805440004 360126-M20A13020002 360126-M20A13020001 360126-M20C18100001 360126-M21113380001 360126-M21404350001 360126-K23100140005 360126-K23100140004 360126-K23100140006 360126-K23100140001 360126-K23100140002 360126-K23100140003 360126-K23200180002 360126-K23200180003 360126-K23200180004 360126-M23222190005 360126-M23222190004 360126-M23222190002 360126-K23200180005 360126-K23200180001 360126-M23222190001 360126-M23222190003 360126-M23402080001 360126-M23402080004 360126-M23402080003 360126-M23402080002 360126-M23402080005 360126-M23402080006 360126-M23810550001 360126-M24308270001 302110-M15A04280003 302110-M15A04280004 302110-M15A04280005 302110-M15A04280002 302110-M15A04280001 302110-M15B04370012 302110-M15B04370013 302110-M15B04370015 302110-M15B04370001 302110-M15B04370002 302110-M15B04370003 302110-M15B04370004 302110-M15B04370007 302110-M15B04370006 302110-M15B04370014 302110-M15B04370008 302110-M15B04370009 302110-M15B04370010 302110-M15B04370011 302110-M15B04370005 260614-M15B05770001 302052-M15C01120005 302052-M15C01120004 302052-M15C01120003 302052-M15C01120001 302052-M15C01120002 302052-M16410920005 302052-M16410920004 302052-M16410920003 302052-M16410920002 302052-M16410920001 261036-M16B04590021 261036-M16B04590020 261036-M16B04590019 261036-M16B04590018 261036-M16B04590017 261036-M16B04590016 261036-M16B04590013 261036-M16B04590014 261036-M16B04590022 261036-M16B04590012 261036-M16B04590011 261036-M16B04590010 261036-M16B04590009 261036-M16B04590015 261036-M16B04590023 261036-M16B04590027 261036-M16B04590025 261036-M16B04590026 261036-M16B04590028 261036-M16B04590029 261036-M16B04590030 261036-M16B04590008 261036-M16B04590006 261036-M16B04590005 261036-M16B04590004 261036-M16B04590003 261036-M16B04590002 261036-M16B04590001 261036-M16B04590024 261036-M16B04590007 261038-M16B08500001 261038-M17101560001 261038-M17101560002 261038-M17101560004 261038-M17101560003 261038-M17101560005 260134-M17109090001 261036-M17207750009 261036-M17207750010 261036-M17207750001 261036-M17207750007 261036-M17207750008 261036-M17207750004 261036-M17207750006 261036-M17207750005 261036-M17207750003 261036-M17207750002 3021320-M17300950001 3021320-M17304090003 3021320-M17304090002 3021320-M17304090001 3021320-M17304100001 261036-M17309070013 261036-M17309070006 261036-M17309070019 261036-M17309070017 261036-M17309070011 261036-M17309070003 261036-M17309070020 261036-M17309070010 261036-M17309070018 261036-M17309070012 261036-M17309070004 261036-M17309070005 261036-M17309070009 261036-M17309070014 261036-M17309070008 261036-M17309070001 261036-M17309070002 261036-M17309070007 261036-M17309070015 261036-M17309070016 3021320-M17402010001 3021320-M17606210004 3021320-M17606210001 3021320-M17606210003 3021320-M17606210002 302121-M17806460005 302121-M17806460001 302121-M17806460003 302121-M17806460004 302121-M17806460002 261038-M18108080001 360126-M18112880003 360126-M18112880008 360126-M18112880009 360126-M18112880005 360126-M18112880004 360126-M18112880010 360126-M18112880001 360126-M18112880002 360126-M18112880007 360126-M18112880006 360126-M18412040001 360126-M18604830002 360126-M18604830003 360126-M18604830001 360126-M18702300003 360126-M18702310002 360126-M18702300001 360126-M18702310001 360126-M18702300002 360126-M18801960004 360126-M18801960003 360126-M18801960002 360126-M18801960001 360126-M18801960005 360126-M18A02130003 360126-M18A02130002 360126-M18A02130005 360126-M18A02130001 360126-M18A02130004 360126-M18C09380001 360126-M19106040003 360126-M19106040001 360126-M19106040002 360126-M19509260005 360126-M19509260004 360126-M19509260001 360126-M19509260002 360126-M19509260003 360126-M19A01920005 360126-M19A01920004 360126-M19A01920002 360126-M19A01920007 360126-M19A01920008 360126-M19A01920006 360126-M19A01920001 360126-M19A01920003 360126-M20201030001 360126-M20201030003 360126-M20200960001 360126-M20201030002 360126-M20302610002 360126-M20302610003 360126-M20302610001 360126-M20302610004 360126-M20302610005 360126-M20311810004 360126-M20311810002 360126-M20311810001 360126-M20311810003 360126-M20311810005 360126-M20901580005 360126-M20901580002 360126-M20901590002 360126-M20901580008 360126-M20901580004 360126-M20901580003 360126-M20901580006 360126-M20901590001 360126-M20901590004 360126-M20901590003 360126-M20901580001 360126-M20901580007 360126-M20A11050002 360126-M20917000001 360126-M20A11050003 360126-M20A11050001 360126-M20917000002 360126-M20917000003 360126-M21303960001 360126-M21A04060001 360126-M21A11760005 360126-M21A11760003 360126-M21A11760004 360126-M21A11760002 360126-M21A11760001 360126-K22300140003 360126-K22300140001 360126-K22300140002 360126-M22501100003 360126-M22501100002 360126-M22501100001 360126-M22502800001 360126-M22602220003 360126-M22602220005 360126-M22602220004 360126-M22602220006 360126-M22602220001 360126-M22602220002 360126-K23100010001 360126-M23303900001 360126-M23303900002 360126-M23705700004 360126-M23705700005 360126-M23705700003 360126-M23705700001 360126-M23705700002 360126-M23915730005 360126-M23915730001 360126-M23915730004 360126-M23915730003 360126-M23915730002 360126-M23C11060001 360126-M24203060005 360126-M24203060003 360126-M24203060008 360126-M24203060004 360126-M24203060002 360126-M24203060006 360126-M24203060001 360126-M24203060007 360126-M24406470001 360126-M24406470002 360126-M24522360001 360126-M24620910002 360126-M24620910004 360126-M24620910001 360126-M24620900001 360126-M24620910003 360126-M24620910005 360126-M24620900002 360126-M24C07650001 360126-M24C26040001 360126-M24C26050001 360126-M25206020001 360126-M25206020004 360126-M25206020002 360126-M25206020003 360126-M25209130003 360126-M25209130001 360126-M25209120002 360126-M25209120001 360126-M25209120003 360126-M25209130002 360126-M25303620001 360126-M25301720002 360126-M25301720005 360126-M25301720004 360126-M25301720003 360126-M25301720001 360126-M25216170003 360126-M25216170001 360126-M25216170002 360126-M25216170004 360126-M25216170005 360126-M25319470002 360126-M25319470003 360126-M25319470005 360126-M25319470001 360126-M25319470004

Distribution pattern

Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.

device · product 14 of 16

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement. Component: No

Z-1153-2026

Recall number: Z-1153-2026
Initiated: October 24, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Edan Diagnostics
Quantity: 12201

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Code information

EDAN Model: M3A UDI-DI code: 06944413800786 Serial/Lot Numbers: 260760-M16406920062 260760-M16406920035 260760-M16406920036 260760-M16406920037 260760-M16406920038 260760-M16406920039 260760-M16406920040 260760-M16406920041 260760-M16406920042 260760-M16406920043 260760-M16406920044 260760-M16406920045 260760-M16406920046 260760-M16406920047 260760-M16406920048 260760-M16406920049 260760-M16406920050 260760-M16406920051 260760-M16406920052 260760-M16406920053 260760-M16406920054 260760-M16406920055 260760-M16406920056 260760-M16406920057 260760-M16406920058 260760-M16406920059 260760-M16406920060 260760-M16406920061 260760-M16406920034 260760-M16406920033 260760-M16406920001 260760-M16406920031 260760-M16406920063 260760-M16406920002 260760-M16406920003 260760-M16406920004 260760-M16406920005 260760-M16406920006 260760-M16406920007 260760-M16406920008 260760-M16406920009 260760-M16406920010 260760-M16406920011 260760-M16406920012 260760-M16406920013 260760-M16406920014 260760-M16406920015 260760-M16406920016 260760-M16406920017 260760-M16406920019 260760-M16406920020 260760-M16406920021 260760-M16406920022 260760-M16406920023 260760-M16406920024 260760-M16406920025 260760-M16406920026 260760-M16406920027 260760-M16406920028 260760-M16406920029 260760-M16406920030 260760-M16406920032 260760-M16406920064 260760-M16406920018 260760-M16406920066 260760-M16406920065 260760-M16406920070 260760-M16406920069 260760-M16406920068 260760-M16406920067 260084-M16408640030 260084-M16408640029 260084-M16408640028 260084-M16408640004 260084-M16408640026 260084-M16408640027 260084-M16408640023 260084-M16408640022 260084-M16408640021 260084-M16408640020 260084-M16408640019 260084-M16408640018 260084-M16408640017 260084-M16408640016 260084-M16408640015 260084-M16408640014 260084-M16408640012 260084-M16408640013 260084-M16408640010 260084-M16408640025 260084-M16408640024 260084-M16408640001 260084-M16408640011 260084-M16408640003 260084-M16408640002 260084-M16408640006 260084-M16408640007 260084-M16408640008 260084-M16408640009 260084-M16408640005 260760-M16604770010 260760-M16604770009 260760-M16604770008 260760-M16604770007 260760-M16604770006 260760-M16604770005 260760-M16604770002 260760-M16604770003 260760-M16604770001 260760-M16604770011 260760-M16604770004 260760-M16604770012 260760-M16604770014 260760-M16604770015 260760-M16604770016 260760-M16604770017 260760-M16604770018 260760-M16604770019 260760-M16604770020 260760-M16604770013 260760-M16604780026 260760-M16604780021 260760-M16604780022 260760-M16604780023 260760-M16604780024 260760-M16604780025 260760-M16604780027 260760-M16604780033 260760-M16604780029 260760-M16604780030 260760-M16604780031 260760-M16604780032 260760-M16604780020 260760-M16604780034 260760-M16604780035 260760-M16604780028 260760-M16604780019 260760-M16604780013 260760-M16604780017 260760-M16604780001 260760-M16604780002 260760-M16604780003 260760-M16604780004 260760-M16604780005 260760-M16604780036 260760-M16604780007 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260760-M16907000024 260760-M16907000023 260760-M16907000022 260760-M16907000021 260760-M16907000020 260760-M16907000019 260760-M16907000018 260760-M16907000015 260760-M16907000017 260760-M16907000016 260760-M16907000013 260760-M16907000001 260760-M16907000002 260760-M16907000003 260760-M16907000004 260760-M16907000005 260760-M16907000006 260760-M16907000007 260760-M16907000008 260760-M16907000009 260760-M16907000012 260760-M16907000011 260760-M16907000014 260760-M16907000010 260727-M16704280010 260727-M16704280031 260727-M16704280024 260727-M16704280028 260727-M16704280023 260727-M16704280032 260727-M16704280027 260727-M16704280026 260727-M16704280022 260727-M16704280021 260727-M16704280020 260727-M16704280018 260727-M16704280017 260727-M16704280016 260727-M16704280015 260727-M16704280014 260727-M16704280025 260727-M16704280001 260727-M16704280003 260727-M16704280008 260727-M16704280013 260727-M16704280034 260727-M16704280101 260727-M16704280036 260727-M16704280108 260727-M16704280107 260727-M16704280106 260727-M16704280105 260727-M16704280104 260727-M16704280103 260727-M16704280029 260727-M16704280099 260727-M16704280097 260727-M16704280095 260727-M16704280035 260727-M16704280085 260727-M16704280081 260727-M16704280077 260727-M16704280090 260727-M16704280054 260727-M16704280037 260727-M16704280038 260727-M16704280062 260727-M16704280040 260727-M16704280041 260727-M16704280042 260727-M16704280039 260727-M16704280044 260727-M16704280046 260727-M16704280047 260727-M16704280048 260727-M16704280050 260727-M16704280043 260727-M16704280030 261023-M16B03030002 261023-M16B03030001 260084-M16B03200001 260084-M16B03200003 260760-M16B03190015 260760-M16B03190016 260760-M16B03190017 260760-M16B03190018 260760-M16B03190019 260760-M16B03190020 260760-M16B03190021 260760-M16B03190022 260760-M16B03190023 260760-M16B03190024 260760-M16B03190025 260760-M16B03190026 260760-M16B03190027 260760-M16B03190028 260760-M16B03190029 260760-M16B03190030 260760-M16B03190031 260084-M16B03200002 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260760-M17401120011 260760-M17401120036 260760-M17401120014 260760-M17401120020 260760-M17401120021 260760-M17401120029 260760-M17401120043 260760-M17401120047 260760-M17401120050 260760-M17401120051 260760-M17401120059 260760-M17401120064 260760-M17401120019 260760-M17401120081 260760-M17401120048 260760-M17401120055 260760-M17401120008 260760-M17401120004 260760-M17401120001 260760-M17401120098 260760-M17401120088 260760-M17401120065 260760-M17401120037 260760-M17401120033 260760-M17401120007 260760-M17401120003 260760-M17401120097 260760-M17401120093 260760-M17401120087 260760-M17401120083 260760-M17401120069 260760-M17401120061 260760-M17401120060 260760-M17401120056 260760-M17401120052 260760-M17401120030 260760-M17401120071 260760-M17401120031 260760-M17401120039 260760-M17401120046 260760-M17401120042 260760-M17401120040 260760-M17401120025 260760-M17401120070 260760-M17401120015 260760-M17401120085 260760-M17401120077 260760-M17401120073 260760-M17401120063 260760-M17401120058 260760-M17401120035 260760-M17401120028 260760-M17401120024 260760-M17401120018 260760-M17401120078 260760-M17401120074 260760-M17401120066 260760-M17401120062 260760-M17401120045 260760-M17401120054 260760-M17401120067 261023-M17405610016 261023-M17405610004 261023-M17405610009 261023-M17405610014 261023-M17405610020 261023-M17405610011 261023-M17405610019 261023-M17405610012 261023-M17405610010 261023-M17405610005 261023-M17405610002 261023-M17405610001 261023-M17405610006 261023-M17405610015 261023-M17405610003 261023-M17405610007 261023-M17405610008 261023-M17405610013 261023-M17405610017 261023-M17405610018 260084-M17506690014 260084-M17506690025 260084-M17506690013 260084-M17506690028 260084-M17506690017 260084-M17506690012 260084-M17506690011 260084-M17506690005 260084-M17506690006 260084-M17506690022 260084-M17506690021 260084-M17506690016 260084-M17506690010 260084-M17506690009 260084-M17506690004 260084-M17506690003 260084-M17506690019 260084-M17506690018 260084-M17506690027 260084-M17506690002 260084-M17506690001 260084-M17506690030 260084-M17506690026 260084-M17506690020 260084-M17506690015 260084-M17506690007 260084-M17506690029 260084-M17506690024 260084-M17506690023 260084-M17506690008 260084-M17608370003 260084-M17608370008 260084-M17608370023 261023-M17608380012 260084-M17608370004 260084-M17608370005 260084-M17608370020 260084-M17608370026 261023-M17608380006 260084-M17608370029 260084-M17608370027 260084-M17608370021 260084-M17608370016 261023-M17608380014 260084-M17608370015 260084-M17608370014 260084-M17608370009 260084-M17608370007 260084-M17608370001 260084-M17608370018 260084-M17608370017 260084-M17608370002 261023-M17608380004 260084-M17608370013 261023-M17608380007 261023-M17608380008 261023-M17608380010 260084-M17608370022 261023-M17608380001 261023-M17608380005 261023-M17608380011 261023-M17608380013 261023-M17608380015 260084-M17608370010 260084-M17608370012 260084-M17608370028 260084-M17608370011 260084-M17608370019 260084-M17608370024 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Distribution pattern

Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.

device · product 15 of 16

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The patient monitor supports software upgrade online and networking and build-in battery power is available for all the models. iM8 Series Patient Monitor can monitor physiological parameters including SpO2, NIBP, ECG, RESP, TEMP, CO2, IBP. The above is the maximum configuration, the user may select different monitoring parameters in according with the requirement. iM8 Series patient monitor includes three models iM8, iM8A, iM8B, and screen size is the primary difference for three models. Component: No

Z-1154-2026

Recall number: Z-1154-2026
Initiated: October 24, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Edan Diagnostics
Quantity: 3141

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Code information

EDAN Model: iM8 UDI-DI code: 06944413801592 Serial/Lot Numbers: 260645-M15C07240016 260645-M15C07240001 260645-M15C07240004 260645-M15C07240005 260645-M15C07240017 260645-M15C07240006 260645-M15C07240007 260645-M15C07240008 260645-M15C07240015 260645-M15C07240009 260645-M15C07240018 260645-M15C07240019 260645-M15C07240020 260645-M15C07240010 260645-M15C07240011 260645-M15C07240012 260645-M15C07240013 260645-M15C07240014 260645-M15C07240002 260645-M15C07240003 260645-M16200530008 260645-M16200530007 260645-M16200530006 260645-M16200530005 260645-M16200530001 260645-M16200530003 260645-M16200530002 260645-M16200530004 260605-M16304610008 260605-M16304610010 260605-M16304610007 260605-M16304610009 260605-M16304610006 260605-M16304610001 260605-M16304610004 260605-M16304610003 260605-M16304610002 260605-M16304610005 260605-K16300150005 260605-K16300150006 260605-K16300150007 260605-K16300150008 260605-K16300150009 260605-K16300150010 260605-K16300150004 260645-M16203940001 260645-M16203940003 260645-M16203940005 260645-M16203940006 260645-M16203940007 260645-M16203940008 260645-M16203940002 260605-K16300150003 260605-K16300150002 260605-K16300150001 260645-M16203940009 260645-M16203940010 260645-M16203940004 260645-M16203940012 260645-M16203940011 260605-M16313860011 260605-M16313860018 260605-M16313860017 260605-M16313860016 260605-M16313860019 260605-M16313860015 260605-M16313860014 260605-M16313860013 260605-M16313860012 260605-M16313860010 260605-M16313860005 260605-M16313860008 260605-M16313860007 260605-M16313860006 260605-M16313860020 260605-M16313860004 260605-M16313860003 260605-M16313860002 260605-M16313860001 260605-M16313860009 260605-M16314840022 260605-M16314840023 260605-M16314840024 260605-M16314840025 260605-M16314840026 260605-M16314840027 260605-M16314840030 260605-M16314840029 260605-M16314840021 260645-M16314850001 260645-M16314850002 260645-M16314850003 260645-M16314850004 260645-M16314850005 260605-M16314840028 260605-M16314840020 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Distribution pattern

Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.

device · product 16 of 16

Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG cables and SpO2 sensors, then achieves data analyzing and processing. After that, data will be sent to MFM-CMS via Wi-Fi. The parameters supported are ECG, SpO2 and PR. Component: No

Z-1155-2026

Recall number: Z-1155-2026
Initiated: October 24, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Edan Diagnostics
Quantity: 1457

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Code information

EDAN Model: iT20 UDI-DI code: 06944413802261 Serial/Lot Numbers: 261350-M17A03030002 261350-M17A03030001 260881-M18407300001 260881-M18407300002 260881-M18407310002 260881-M18407310001 260881-M18703320002 260881-M18703320004 260881-M18703320001 260881-M18703320003 260881-M18800890008 260881-M18800890003 260881-M18800890004 260881-M18800890005 260881-M18800890007 260881-M18800890001 260881-M18800890006 260881-M18800890002 260881-M18800890010 260881-M18810400010 260881-M18810400009 260881-M18810400008 260881-M18810400004 260881-M18810400003 260881-M18810410008 260881-M18810410006 260881-M18810410002 260881-M18810400007 260881-M18810400002 260881-M18810400001 260881-M18810410003 260881-M18810410007 260881-M18810410001 260881-M18810410010 260881-M18810410005 260881-M18810410009 260881-M18810410004 260881-M18810400005 260881-M18810400006 260881-M18901010006 260881-M18901000007 260881-M18901000009 260881-M18901000012 260881-M18901000017 260881-M18901000018 260881-M18901000002 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Distribution pattern

Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.