Device recall
Z-0971-2009: 3.7 V Li-Polymer Battery, used in Precess MRI Compatible Patient Monitoring…
FDA device recall · Class II · Invivo Corporation
Key facts
| Recall number (Z-number) | Z-0971-2009 |
|---|---|
| Recall event | 50790 |
| Product | 3.7 V Li-Polymer Battery, used in Precess MRI Compatible Patient Monitoring System and Achieva, Intera and Panorama 1.0T. REF 9065 or REF 9067. Invivo Corporation, Orlando, FL 32826 These rechargeable batteries are used to supply power to patient monitoring system's wireless modules and… |
| Product code | MWI |
| Recalling firm | Invivo Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 19, 2010 |
| 510(k) numbers | K053462, K063559 |
| FEI number | 1051786 |
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