Drug recall
Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defibrillator.
FDA recall event 67857 · Class II · Philips Medical Systems, Inc.
Key facts
| Event ID | 67857 |
|---|---|
| Recall numbers | Z-1439-2014 |
| Recalling firm | Philips Medical Systems, Inc. |
| Product type | Devices |
| Products | Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defibrillator. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy |
| Initiation date | Mar 31, 2014 |
| Report date | Apr 16, 2014 |
| Termination date | Oct 21, 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: