Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77599

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

Open FDA event record

Event summary

Timeline bucket
May 01, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Toshiba American Medical Systems 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

5 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 5

XARIO 100 TUS-X100 diagnostic ultrasound system

Z-2708-2017
Recall number
Z-2708-2017
Initiated
May 01, 2017
Classification
Class II
Status
Terminated
Quantity
7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.

Code information

Serial Numbers: W5B16Z2555, W5B1712642, MXA1723100, MXA1723098, MXA1723101, MXA1723099, MXA1723097

Distribution pattern

Nationwide Distribution

device · product 2 of 5

XARIO 200 TUS-X200 diagnostic ultrasound system

Z-2709-2017
Recall number
Z-2709-2017
Initiated
May 01, 2017
Classification
Class II
Status
Terminated
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.

Code information

Serial Number W5B1712472

Distribution pattern

Nationwide Distribution

device · product 3 of 5

APLIO 300 TUS-A300 diagnostic ultrasound system

Z-2710-2017
Recall number
Z-2710-2017
Initiated
May 01, 2017
Classification
Class II
Status
Terminated
Quantity
90 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.

Code information

Serial Numbers: AAC1692086, AAC1692087, AAC1692088, AAC1692089, AAC1692090, AAC16Y2091, AAC16Y2092, AAC16Y2093, AAC16Y2094, AAC16Y2095, AAC16Y2096, AAC16Y2097, AAC16Y2098, AAC16Y2099, AAC16Y2100, AAD16Z2101, AAD16Z2102, AAD16Z2103, AAD16Z2104, AAD16Z2105, AAD1712106, AAD1712107, AAD1712108, AAD1712109, AAD1712110, AAD1712111, AAD1712112, AAD1722114, AAD1722115, AAD1722116, AAD1722117, AAA1652011, AAA1652012, AAA1652013, AAA1652014, AAA1652015, AAA1672026, AAA1672027, AAA1672028, AAA1672029, AAA1672030, AAA1672031, AAA1672032, AAA1672033, AAA1672034, AAA1672035, AAA1672036, AAA1672037, AAA1672038, AAA1672040, AAA1682041, AAA1682042, AAA1682043, AAA1682044, AAA1682045, AAA1682046, AAA1682047, AAA1682048, AAA1682049, AAA1682051, AAA1682052, AAA1682053, AAA1682054, AAA1692056, AAA1692057, AAA1692058, AAA1692059, AAA1692060, AAA1712011, AAA1712012, AAA1712013, AAA1712014, AAA1712015, AAA1712016, AAA1712017, AAA1722022, AAA1722023, AAA1722024, AAA1722036, AAA1722038, AAA1722039, AAA1722040, AAA1722041, AAA1722042, AAA1722043, AAA1722044, AAA1722045, AAA1732046, AAA1732047, AAA1732049.

Distribution pattern

Nationwide Distribution

device · product 4 of 5

APLIO 500 TUS-A500 diagnostic ultrasound system

Z-2711-2017
Recall number
Z-2711-2017
Initiated
May 01, 2017
Classification
Class II
Status
Terminated
Quantity
307 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.

Code information

Serial Numbers: AAC1652199, AAC1652200, AAC1652201, AAC1652202, AAC1652203, AAC1652204, AAC1652205, AAC1652206, AAC1652207, AAC1652208, AAC1662209, AAC1662210, AAC1662211, AAC1662212, AAC1662213, AAC1662214, AAC1662215, AAC1662216, AAC1662217, AAC1662218, AAC1662219, AAC1662220, AAC1662221, AAC1662222, AAC1662223, AAC1672224, AAC1672225, AAC1672226, AAC1672227, AAC1672228, AAC1672229, AAC1672230, AAC1672231, AAC1672232, AAC1672233, AAC1692234, AAC1692235, AAC1692236, AAC1692237, AAC1692238, AAC1692239, AAC1692240, AAC1692241, AAC1692242, AAC1692243, AAC1692244, AAC1692245, AAC1692246, AAC1692247, AAC1692248, AAC1692249, AAC1692250, AAC1692251, AAC1692252, AAC1692253, AAC16X2254, AAC16X2255, AAC16X2256, AAC16X2257, AAC16X2258, AAC16X2259, AAC16X2260, AAC16X2261, AAC16X2262, AAC16X2263, AAC16Y2264, AAC16Y2265, AAC16Y2266, AAC16Y2267, AAC16Y2268, AAC16Y2269, AAC16Y2270, AAC16Y2271, AAC16Y2272, AAC16Y2273, AAC16Y2275, AAC16Y2276, AAC16Y2278, AAC16Y2279, AAC16Y2280, AAC16Y2281, AAC16Y2282, AAC16Y2283, AAC16Y2284, AAC16Y2285, AAC16Y2286, AAC16Y2287, AAC16Y2288, AAC16Y2289, AAC16Y2290, AAC16Y2291, AAC16Y2292, AAC16Y2293, AAD16Z2297, AAD16Z2298, AAD16Z2299, AAD16Z2300, AAD16Z2301, AAD16Z2302, AAD16Z2308, AAD16Z2309, AAD16Z2310, AAD16Z2311, AAD16Z2312, AAD16Z2313, AAD16Z2314, AAD16Z2315, AAD16Z2316, AAD1712317, AAD1712318, AAD1712319, AAD1712320, AAD1712321, AAD1712322, AAA1652007, AAA1652008, AAA1652009, AAA1652010, AAA1652011, AAA1652012, AAA1652014, AAA1652015, AAA1652016, AAA1652017, AAA1652018, AAA1652019, AAA1652020, AAA1652021, AAA1652022, AAA1652023, AAA1652024, AAA1652025, AAA1662076, AAA1662077, AAA1662078, AAA1662079, AAA1662080, AAA1662081, AAA1662082, AAA1662083, AAA1662084, AAA1662085, AAA1662086, AAA1662087, AAA1662088, AAA1662090, AAA1662091, AAA1662092, AAA1662093, AAA1672105, AAA1672106, AAA1672107, AAA1672108, AAA1672109, AAA1672110, AAA1672111, AAA1672112, AAA1672113, AAA1672114, AAA1672116, AAA1672117, AAA1672118, AAA1672119, AAA1672120, AAA1672121, AAA1672122, AAA1672123, AAA1672124, AAA1672125, AAA1672126, AAA1672127, AAA1672128, AAA1672129, AAA1672130, AAA1672131, AAA1672132, AAA1672133, AAA1672134, AAA1672135, AAA1672137, AAA1672141, AAA1672143, AAA1672144, AAA1672145, AAA1682146, AAA1682147, AAA1682148, AAA1682149, AAA1682150, AAA1682151, AAA1682152, AAA1682153, AAA1682154, AAA1682155, AAA1682156, AAA1682157, AAA1682158, AAA1682159, AAA1682162, AAA1692171, AAA1692172, AAA1692173, AAA1692174, AAA1692175, AAA1692176, AAA1692178, AAA1692179, AAA1692180, AAA6172101, AAA16Z2006, AAA16Z2007, AAA16Z2008, AAA16Z2009, AAA16Z2010, AAA16Z2011, AAA16Z2012, AAA16Z2013, AAA16Z2014, AAA16Z2016, AAA16Z2017, AAA16Z2018, AAA16Z2019, AAA16Z2020, AAA16Z2021, AAA16Z2022, AAA16Z2023, AAA16Z2024, AAA16Z2025, AAA16Z2026, AAA16Z2027, AAA16Z2028, AAA16Z2029, AAA16Z2030, AAA1712031, AAA1712032, AAA1712033, AAA1712034, AAA1712035, AAA1712036, AAA1712037, AAA1712038, AAA1712039, AAA1712042, AAA1712043, AAA1712044, AAA1712045, AAA1722046, AAA1722047, AAA1722048, AAA1722049, AAA1722050, AAA1722051, AAA1722052, AAA1722053, AAA1722054, AAA1722055, AAA1722056, AAA1722057, AAA1722058, AAA1722059, AAA1722060, AAA1722062, AAA1722076, AAA1722084, AAA1722086, AAA1722087, AAA1722088, AAA1722089, AAA1722090, AAA1722091, AAA1722092, AAA1722093, AAA1722094, AAA1722095, AAA1722101, AAA1722102, AAA1722103, AAA1722104, AAA1722105, AAA1722106, AAA1722107, AAA1722108, AAA1722109, AAA1722110, AAA1722111, AAA1722112, AAA1722113, AAA1722114, AAA1722115, AAA1722116, AAA1722117, AAA1722118, AAA1722119, AAA1722120, AAA1722121, AAA1722122, AAA1722123, AAA1722124, AAA1722125, AAA1722126, AAA1722127, AAA1722128, AAA1722129, AAA1732136, AAA1732137, AAA1732138, AAA1732139, AAA1732140.

Distribution pattern

Nationwide Distribution

device · product 5 of 5

APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic ultrasound system

Z-2712-2017
Recall number
Z-2712-2017
Initiated
May 01, 2017
Classification
Class II
Status
Terminated
Quantity
28 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.

Code information

Serial Numbers: a) JHA16X2002, HAB16Z2001, HAB16Z2002, HAB16Z2003, HAB16Z2004, HAB16Z2005, HAB1732007, HAB1732009 b) HAB16Z2002, HAB16Z2003, HAB1712006, HAB1712007, HAB1712008, HAB1712009, HAB1712010, HAB1722011, HAB1722012, HAB1732013, HAB1732014, HAB1732015, HAB1732016, HAB1732017, HAB1732018, HAB1732020, HAB1732021, HAB1732025, HAB1732027, HAB1732030

Distribution pattern

Nationwide Distribution