Drug recall
Invivo Expression MRI Patient Monitoring System.
FDA recall event 71541 · Class II · Philips Electronics North America Corporation
Key facts
| Event ID | 71541 |
|---|---|
| Recall numbers | Z-2266-2015 |
| Recalling firm | Philips Electronics North America Corporation |
| Product type | Devices |
| Products | Invivo Expression MRI Patient Monitoring System. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The device's labeling inaccurately indicates Endotracheal as a body temperature application site. The FlexTEMP reusable temperature sensor is not intended to be used for endotracheal placement. The… |
| Initiation date | Jun 17, 2015 |
| Report date | Aug 5, 2015 |
| Termination date | Oct 2, 2019 |
| City | Andover |
| State | MA |
| Country | United States |
| FEI number | 1218950 |
At a glance
- 1–9 Products in this recall
- None 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: