[Recalled] Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system. — Toshiba Medical Systems has received reports of startup issues with the Toshiba… | FDA 2012-12-
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system. |
|---|---|
| Brand / manufacturer | Toshiba American Medical Systems Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1104-2013 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 11 December 2012 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Toshiba American Medical Systems Inc
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.