Device recall
Z-0478-2011: The software is ARM version 60.80.101.025 (referred to as Nano 1.0.5). The…
FDA device recall · Class III · Sonosite, Inc.
Key facts
| Recall number (Z-number) | Z-0478-2011 |
|---|---|
| Recall event | 56428 |
| Product | The software is ARM version 60.80.101.025 (referred to as Nano 1.0.5). The software is used with the SonoSite NanoMaxx ultrasound system. |
| Product code | IYN |
| Recalling firm | Sonosite, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 21, 2011 |
| 510(k) numbers | K092058 |
| FEI number | 3002087856 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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