Drug recall
M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use for the termination of…
FDA recall event 67481 · Class II · Philips Medical Systems, Inc.
Key facts
| Event ID | 67481 |
|---|---|
| Recall numbers | Z-1108-2014 |
| Recalling firm | Philips Medical Systems, Inc. |
| Product type | Devices |
| Products | M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Wireless Link may be unable to transmit data when configured for a specific data flow. |
| Initiation date | Feb 18, 2014 |
| Report date | Mar 5, 2014 |
| Termination date | Nov 12, 2015 |
| 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: