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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Toshiba American Medical Systems Inc: 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.

Agency Publication Date: July 10, 2017
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Affected Products

Product: XARIO 100 TUS-X100 diagnostic ultrasound system

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

Product: XARIO 200 TUS-X200 diagnostic ultrasound system

Serial Number W5B1712472

Product: APLIO 300 TUS-A300 diagnostic ultrasound system

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.

Product: APLIO 500 TUS-A500 diagnostic ultrasound system

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.

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

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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 77599
Status: Resolved
Manufacturer: Toshiba American Medical Systems Inc
Manufactured In: United States
Units Affected: 5 products (7 units; 1 unit; 90 units; 307 units; 28 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.