XARIO 100 TUS-X100 diagnostic ultrasound system — Class II medical device recall Z-2708-2017
Terminated recall by Toshiba American Medical Systems Inc, reported 2017-07-19, distributed nationwide. When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement,
| Recall number | Z-2708-2017 |
|---|---|
| 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 | 2017-05-01 |
| Classified | 2017-07-10 |
| Reported by FDA | 2017-07-19 |
| Terminated | 2023-10-11 |
| Distributed | Nationwide (US) |
| Quantity | 7 units |
| Serial numbers | MXA1723097, MXA1723098, MXA1723099, MXA1723100, MXA1723101, W5B16Z2555, W5B1712642 |
Product
XARIO 100 TUS-X100 diagnostic ultrasound system
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.
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-2708-2017. 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.