Xario 100 Diagnostic Ultrasound System — Class II medical device recall Z-2542-2016
Terminated recall by Toshiba American Medical Systems Inc, reported 2016-08-24. Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ultrasound System because it may be
| Recall number | Z-2542-2016 |
|---|---|
| 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 | 2016-08-04 |
| Classified | 2016-08-16 |
| Reported by FDA | 2016-08-24 |
| Terminated | 2017-11-17 |
| Quantity | 93 units |
| Reason classes | software |
Product
Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.
Reason for recall
Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ultrasound System because it may become hot because of a software error.
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-2542-2016. 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.