APLIO 500 TUS-A500 diagnostic ultrasound system
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Toshiba American Medical Systems Inc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
APLIO 500 TUS-A500 diagnostic ultrasound system
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2711-2017
Related Recalls
Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the main power switch on the rear of the system is set to ON.
Toshiba American Medical Systems
The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the main power switch on the rear of the system is set to ON.
INFX-8000C Fluoroscopic X-Ray Systems
Toshiba American Medical Systems
During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.
INFX-8000F Fluoroscopic X-Ray Systems
Toshiba American Medical Systems
During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.