Drug recall
Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a…
FDA recall event 71584 · Class II · Philips Electronics North America Corporation
Key facts
| Event ID | 71584 |
|---|---|
| Recall numbers | Z-2328-2015 |
| Recalling firm | Philips Electronics North America Corporation |
| Product type | Devices |
| Products | Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Multiple software and hardware issues with device that can affect its function. |
| Initiation date | Jun 5, 2015 |
| Report date | Aug 12, 2015 |
| Termination date | Feb 25, 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: