Drug recall
HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight…
FDA recall event 83576 · Class II · Philips North America, LLC
Key facts
| Event ID | 83576 |
|---|---|
| Recall numbers | Z-2488-2019 |
| Recalling firm | Philips North America, LLC |
| Product type | Devices |
| Products | HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Non-conforming devices are identified, which may not have been included in prior field actions and may not have had a number of corrections applicable to these devices. |
| Initiation date | Jul 16, 2019 |
| Report date | Sep 18, 2019 |
| Termination date | Oct 20, 2022 |
| 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: