Aplio 500/400/300 Diagnostic Ultrasound System — Class II medical device recall Z-1104-2013
Terminated recall by Toshiba American Medical Systems Inc, reported 2013-04-24, distributed nationwide. Toshiba Medical Systems has received reports of startup issues with the Toshiba TUS-500 and TUS-300 ultrasound
| Recall number | Z-1104-2013 |
|---|---|
| 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 | 2012-12-11 |
| Classified | 2013-04-12 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2014-04-10 |
| Distributed | Nationwide (US) |
| Quantity | 233 units |
| Model numbers | TUS-A300/WL, TUS-A500/WL |
Product
Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.
Reason for recall
Toshiba Medical Systems has received reports of startup issues with the Toshiba TUS-500 and TUS-300 ultrasound systems. The startup issue is predominant when attempting to bring the system up from standby mode when the system is used remotely. It has been determined that this may potentially cause damage to the system.
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-1104-2013. 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.