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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94475

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

Open FDA event record

Event summary

Timeline bucket
March 26, 2024
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Philips Respironics, Inc.

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

3 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 3

BiPAP V30 Auto Ventilator, Part Number 1111178

Z-1812-2024
Recall number
Z-1812-2024
Initiated
March 26, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Philips Respironics, Inc.
Quantity
5,958 US; None OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.

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

Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.

Code information

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Distribution pattern

Worldwide distribution. US Nationwide including PR and GU; Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, and Turkey.

device · product 2 of 3

BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111169 R1111169 R1111177 R1116156 ; BiPAP A40 Pro, Part Numbers (OUS Only): ARX3100S19 AUX3100S19 BLX3100S19 BRX3100S18 CAX3100S12 CAX3100T12 DEX3100S13 EEX3100S19 ESX3100S19 FRX3100S14 GBX3100H19 GBX3100S19 IAX3100S19 INX3100H19 INX3100S19 ITX3100S21 SPX3100S19 ; BiPAP A40 EFL, Part Numbers (OUS Only): AUX3000S19 DEX2900S13 DEX3000S13 EEX3000S19 ESX3000S19 FRX3000S14 GBX3000S19 INX3000H19 ITX3000S21

Z-1813-2024
Recall number
Z-1813-2024
Initiated
March 26, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Philips Respironics, Inc.
Quantity
6 US, 60,417 OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.

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

Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.

Code information

US: Material No. 1111169 UDI-DI 00606959039476 Serial Numbers V182393118CC9 V21942863DD70 V219429359C22 V25585948745C V26439189762A V2640770372E7 OUS: A40: Material No. 1111169 UDI-DI 00606959039476 Serial Numbers V09765327781A V09765332366F V097653405875 V097653436AEE V097653472CCA V0976535041AD V097653551600 V09765356249B V09765358CDE5 V100863961519 V10086398FC67 V10086399EDEE V100864020820 V10086408A77A V1008641032EA V100864112363 V100864130071 V1008641474CE V100864201882 V100864223B90 V100864276C3D V10086436646C V100864388D12 V100864399C9B V100864426F40 V100864437EC9 V100864462964 V10086448C01A V10086450558A V100864514403 V100864527698 V100864536711 V100864550227 V1008645630BC V10086459C84B V100864616E6B V100864634D79 V1008646439C6 V10086465284F V100864670B5D V10086468F3AA V1008643333C1 V1008647177B3 V100864724528 V100864771285 V10086478EA72 V10086479FBFB V1008648869BA V100864013ABB V100864267DB4 V100864451BFF V10086458D9C2 V100864625CF0 V100864753197 V10086484A3D6 V10086476030C V10086509EC2F V100865489AC6 V10086482C6E0 V1008643556F7 V100865124B24 V100865262768 V10086528CE16 V100865454123 V100864002B32 V100864415DDB V10086469E223 V1008650437CA V1008652370C5 V1008640319A9 V10086485B25F V10271624DE95 V10271625CF1C V10271627EC0E V1027162814F9 V102716290570 V102716308169 V1027163190E0 V10271633B3F2 V10271664B9F5 V102716943A3D V102716952BB4 V10271696192F V10271698F051 V10271699E1D8 V10271700F1DD V10271704B7F9 V1027170694EB V10271711F98C V10271712CB17 V10271713DA9E V10271714AE21 V10271726A75B V10271727B6D2 V10307238112D V103072449649 V10307246B55B V10307252EAA7 V103072548F91 V10307256AC83 V10307257BD0A V103072595474 V10307260E3DD V10307261F254 V10307262C0CF V10307265B470 V103072679762 V103072697E1C V10307271EB8C V10307274BC21 V10086542359C V10307250C9B5 V10307251D83C V1030726686EB V10307410780C V103074134A97 V103074161D3A V103074304BBC V1030742143ED V10390418F201 V102716082749 V102716183E91 V103072485C25 V10307272D917 V10307273C89E V103074116985 V10307438C7F4 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Distribution pattern

Worldwide distribution. US Nationwide including PR and GU; Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, and Turkey.

device · product 3 of 3

BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR1111143 CN1111143 R1111143 R1111150 R1111181

Z-1814-2024
Recall number
Z-1814-2024
Initiated
March 26, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Philips Respironics, Inc.
Quantity
3 US; 21,414 OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.

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

Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.

Code information

US distribution: Material No. 1111143 UDI-DI 00606959039308 Serial Numbers N182942836566 N14644718E852 N16489657EE4B -- OUS distribution: Material No. 1111143 UDI-DI 606959067493 Serial Nos. N09765363D900 N09765365BC36 N097653668EAD N097653679F24 N102712420C4C N102712431DC5 N1027125470A2 N10271255612B N1027125653B0 N10271258BACE N10271259AB47 N102712601CEE N102712610D67 N102712623FFC N102712632E75 N102712654B43 N1027126679D8 N1027126890A6 N102712700536 N1027127114BF N10271275529B N102712777189 N10271282A5EC N10271283B465 N10271285D153 N10271287F241 N102712880AB6 N102712891B3F N102712909F26 N10271292BC34 N10271293ADBD N10271294D902 N10271295C88B N10271297EB99 N10271298136E N1027129902E7 N1027130012E2 N10271307665D N102713089EAA N102713100B3A N102713122828 N102713155C97 N102713177F85 N1027131996FB N1027132313C9 N1027132576FF N10271329BC93 N102713356F27 N102713365DBC N102713374C35 N102713517DD3 N10271356096C N102713626520 N102713714E63 N102713727CF8 N10271390C5FA N10271410873F N1027141196B6 N10271413B5A4 N10271428211F N10271439294E N10271440F987 N10271442DA95 N10271443CB1C N102714496446 N10271473E174 N1027147495CB N102714758442 N10271476B6D9 N10271477A750 N102714794E2E N102714841603 N10271489CDE6 N102714926AED N102714951E52 N10271499D43E N10271503F6A0 N10271504821F N102715059396 N10271506A10D N10271511CC6A N10271513EF78 N1027151851AB N10271520F78B N10271521E602 N10271522D499 N10271523C510 N10271524B1AF N102715278334 N10271530EE53 N10271531FFDA N10271533DCC8 N102715368B65 N102715379AEC N102715397392 N102715428049 N1027154391C0 N10271547D7E4 N102715482F13 N10271550BA83 N10271551AB0A N102715538818 N10271554FCA7 N10271556DFB5 N10271557CE3C N1027156090EB N102715618162 N10271563A270 N10271565C746 N10271566F5DD N102715681CA3 N102715690D2A N102715708933 N1027157198BA N10271573BBA8 N10271576EC05 N102715811B72 N1027158229E9 N102715844CDF N102715855D56 N102715866FCD N102715877E44 N102715901323 N1027159102AA N1027159321B8 N102715967615 N102715998EE2 N102716002B5F N10271602084D N1027160319C4 N102716075FE0 N103072047177 N1030720560FE N103072065265 N10307208BB1B N103072120D99 N103072131C10 N103072164BBD N1030722004E3 N1030722442C7 N10307225534E N1030722661D5 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N17880317E7D4 N178803181F23 N178803190EAA N17880321A88A N178803229A11 N178803238B98 N17880324FF27 N17880325EEAE N17880326DC35 N17880327CDBC N17880328354B N1788032924C2 N17880330A0DB N17880331B152 N1788033283C9 N178803339240 N17880334E6FF N17880335F776 N17880336C5ED N17880337D464 N178803382C93 N178803393D1A N17880340EDD3 N17880341FC5A N17880342CEC1 N17880343DF48 N17880344ABF7 N17880345BA7E N17880351E582 N17880354B22F N17880356913D N1788035969CA N17880362FD71 N17880363ECF8 N178803649847 N1788036589CE N17880367AADC N17880368522B N1788036943A2 N17880370C7BB N17880371D632 N17880372E4A9 N17880373F520 N17880374819F N178803759016 N17880376A28D N17880377B304 N178803784BF3 N178803795A7A N178803804473 N1788038155FA N178803826761 N1788038376E8 N178803840257 N17892204A479 N17892205B5F0 N178922086E15 N178922097F9C N17892210FB85 N17892211EA0C N17892212D897 N17892213C91E N17892214BDA1 N17892215AC28 N178922169EB3 N178922178F3A N1789221877CD N178922196644 N17892220D1ED N17892221C064 N17892222F2FF N17892223E376 N1789222497C9 N178922258640 N17892226B4DB N17892227A552 N178922294C2C N17892230C835 N17892231D9BC N17892232EB27 N17892233FAAE N178922348E11 N178922359F98 N17892236AD03 N17892237BC8A N17892238447D N1789223955F4 N17892240853D N1789224194B4 N17892242A62F N17892243B7A6 N17892244C319 N17892245D290 N17892246E00B N17892247F182 N178922480975 N1789224918FC N178922509CE5 N178922518D6C N17892252BFF7 N17892253AE7E N17892254DAC1 N17892255CB48 N17892256F9D3 N17892257E85A N1789225810AD N178922590124 N17892260B68D N17892261A704 N17892262959F N178922638416 N17892264F0A9 N17892265E120 N17892266D3BB N17892267C232 N178922683AC5 N178922692B4C N178922728C47 N178922739DCE N17892275F8F8 N17892276CA63 N18294277A08A N1829427949F4 N1829428057FD N182942814674 N1829428411D9 N182942850050 N1829428632CB N182942872342 N18294289CA3C N182942904E25 N182942915FAC N182942926D37 N182942937CBE N182942940801 N182942962B13 N18294298C26D N18294299D3E4 N18294300C3E1 N18294301D268 N18294303F17A N1829430485C5 N18294307B75E N182943084FA9 N182943095E20 N18294310DA39 N18294311CBB0 N18294312F92B N182943149C1D N18294317AE86 N1829431947F8 N18294323C2CA N18294324B675 N18294325A7FC N18294330E989 N18294331F800 N18294332CA9B N18294333DB12 N182943368CBF N1829433865C1 N182943397448 N18294341B508 N18294343961A N18294347D03E N1829434828C9 N18294350BD59 N18294351ACD0 N182943538FC2 N18294355EAF4 N18294356D86F N18294362B423 N18294364D115 N18294366F207 N182943681B79 N182943690AF0 N182943719F60 N18294373BC72 N18294376EBDF N18294377FA56 N182943791328 N182943822E33 N182943833FBA N182943855A8C N18294387799E N183875301

Distribution pattern

Worldwide distribution. US Nationwide including PR and GU; Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, and Turkey.