Device recall
Z-0126-2021: MR Coils The MR Coil is intended to be used in conjunction with a Magnetic…
FDA device recall · Class III · Invivo Corporation
Key facts
| Recall number (Z-number) | Z-0126-2021 |
|---|---|
| Recall event | 86501 |
| Product | MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician. |
| Product code | MOS |
| Recalling firm | Invivo Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 14, 2023 |
| 510(k) numbers | K033567, K053017, K103149, K162001 |
| FEI number | 1000113495 |
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