Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine… — Class II medical device recall Z-0122-2014
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-0122-2014 |
|---|---|
| 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 | 99B06Y2048, 99B06Y2049, 99B06Y2050, 99B06Y2051, 99B06Z2055, 99B06Z2056, 99B06Z2057, 99B06Z2058, 99B06Z2060, 99B06Z2061, 99B06Z2062, 99B06Z2063, 99B06Z2064, 99B06Z2066, 99B06Z2067, 99B06Z2068, 99B06Z2069, 99B06Z2070, 99B06Z2071, 99B06Z2072, 99B06Z2073, 99B06Z2074, 99B06Z2075, 99B06Z2088, 99B06Z2090 and 406 more |
Product
Aplio XG Diagnostic Ultrasound System SSA-790A 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
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0122-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.