Device recall
Z-0983-2014: Invivo Corporation Expression Information Portal (Model IP5) is intended to be…
FDA device recall · Class II · Invivo Corporation
Key facts
| Recall number (Z-number) | Z-0983-2014 |
|---|---|
| Recall event | 67387 |
| Product | Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display control unit, where the device monitors the vital signs of a patient undergoing an MRI procedure from the MR control room, induction room, or recovery room and then outputs the measured patient… |
| Product code | MWI |
| Recalling firm | Invivo Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 12, 2016 |
| 510(k) numbers | K121424 |
| 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