Drug recall
HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external…
FDA recall event 79982 · Class II · Philips Electronics North America Corporation
Key facts
| Event ID | 79982 |
|---|---|
| Recall numbers | Z-2035-2018 |
| Recalling firm | Philips Electronics North America Corporation |
| Product type | Devices |
| Products | HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) Product Usage: The HeartStart MRx is for use for the… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component. Failure to charge could potentially cause… |
| Initiation date | May 3, 2018 |
| Report date | Jun 6, 2018 |
| Termination date | Oct 17, 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: