Drug recall
Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic…
FDA recall event 64693 · Class II · Toshiba American Medical Systems Inc
Key facts
| Event ID | 64693 |
|---|---|
| Recall numbers | Z-1104-2013 |
| Recalling firm | Toshiba American Medical Systems Inc |
| Product type | Devices |
| Products | Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Dec 11, 2012 |
| Report date | Apr 24, 2013 |
| Termination date | Apr 10, 2014 |
| City | Tustin |
| State | CA |
| Country | United States |
| FEI number | 2020563 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: