Device recall
Z-0253-2008: NEMIO Ultrasound System, Model SSA-550A, Software versions: V3.1.000B, V3.5.0…
FDA device recall · Class III · Toshiba American Med Sys Inc
Key facts
| Recall number (Z-number) | Z-0253-2008 |
|---|---|
| Recall event | 44811 |
| Product | NEMIO Ultrasound System, Model SSA-550A , Software versions: V3.1.000B, V3.5.0, V3.5.000A, V3.5.000B, V3.6.0, V3.6.000A, V4.0.0, V4.0.000A, V4.l.0, V4.l.000A, V4.2.0, V4.3.0, V4.5.0, V4.5.000A, Toshiba America Medical Systems, Inc., Tustin, CA. |
| Product code | IYO |
| Recalling firm | Toshiba American Med Sys Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 5, 2012 |
| 510(k) numbers | K043078 |
| FEI number | 2020563 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database