Drug recall
MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce…
FDA recall event 86501 · Class III · Invivo Corporation
Key facts
| Event ID | 86501 |
|---|---|
| Recall numbers | Z-0126-2021 |
| Recalling firm | Invivo Corporation |
| Product type | Devices |
| Products | 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. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress. |
| Initiation date | Sep 14, 2020 |
| Report date | Oct 28, 2020 |
| Termination date | Aug 14, 2023 |
| City | Gainesville |
| State | FL |
| Country | United States |
| FEI number | 1000113495 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: