Device recall
Z-0113-2012: Radio used in the Precess MRI Patient Monitoring System. 3160 (Precess) and…
FDA device recall · Class II · Invivo Corporation
Key facts
| Recall number (Z-number) | Z-0113-2012 |
|---|---|
| Recall event | 60025 |
| Product | Radio used in the Precess MRI Patient Monitoring System. 3160 (Precess) and HE97B, 94044, 94045 (radio and radio kits). Label located on the back of the WPU. Product is labeled in part: "***Invivo Corporation 12601 Research Parkway, Orlando, FL 32826***Made in U.S.A.***REF 3160***SN***CAUTION: Law… |
| Product code | MWI |
| Recalling firm | Invivo Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 7, 2013 |
| 510(k) numbers | K053462 |
| 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