Drug recall
HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular…
FDA recall event 73825 · Class II · Philips Electronics North America Corporation
Key facts
| Event ID | 73825 |
|---|---|
| Recall numbers | Z-1612-2016 |
| Recalling firm | Philips Electronics North America Corporation |
| Product type | Devices |
| Products | HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component. |
| Initiation date | Apr 14, 2016 |
| Report date | May 11, 2016 |
| Termination date | Mar 27, 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: