Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine… — Class II medical device recall Z-0121-2014
Terminated recall by Toshiba American Medical Systems Inc, reported 2013-11-06, distributed nationwide. The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that
| Recall number | Z-0121-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Toshiba American Medical Systems Inc, Tustin, CA, United States |
| Recall initiated | 2013-08-05 |
| Classified | 2013-10-30 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2016-06-28 |
| Distributed | Nationwide (US) |
| Serial numbers | 99A09X2086, 99A09X2087, 99A09X2089, 99A09X2090, 99A09X2091, 99A09X2092, 99A09X2093, 99A09X2094, 99A09X2095, 99A09Y2113, 99A09Y2114, 99A09Y2116, 99A09Y2117, 99A09Y2118, 99A09Y2119, 99A09Y2120, 99B09Z2170, 99B09Z2171, 99B09Z2172, 99B09Z2173, 99B09Z2174, 99B09Z2178, 99B09Z2179, 99B09Z2180, 99B09Z2181 and 402 more |
Product
Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging
Reason for recall
The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.