FDA Device recall Z-1104-2013
Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300)
- FDA Device
- Class II
- terminated
- Published 2013-04-24
On 2013-04-24 the FDA classified a Class II recall of Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300) by Toshiba American Medical Systems, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1104-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-12-11 |
| Published | 2013-04-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Toshiba American Medical Systems |
| Distribution | US |
Product
Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.
Reason
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.
Identifiers
| code_info | Item numbers: TUS-A300/Wl and TUS-A500/Wl |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1104-2013%22
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