Drug recall
HeartStart XL+ Defibrillator/Monitor, Model 861290
FDA recall event 84115 · Class II · Philips North America, LLC
Key facts
| Event ID | 84115 |
|---|---|
| Recall numbers | Z-0498-2020 |
| Recalling firm | Philips North America, LLC |
| Product type | Devices |
| Products | HeartStart XL+ Defibrillator/Monitor, Model 861290 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behaviors include: The device may not turn on; The device may not perform the selected function; The device… |
| Initiation date | Oct 16, 2019 |
| Report date | Nov 27, 2019 |
| Termination date | Nov 29, 2023 |
| 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: