Recall Z-2488-2019 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips North America, LLC
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 mode and semi-automatic mode (AED). In manual mode, the HeartStart MRx is a full featured manual defibrillator, designed for use by clinicians trained in Advanced Cardiac Life Support (ACLS). Manual ope
| Date | Jul 16, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 1. Locate the MRx devices M3535A with the serial numbers US00539461 and US00539462. 2. Remove them from clinical use and quarantine these two devices in a secure location. 3. A Philips representative will contact you to arrange for the removal of the affected HeartStart MRx devices and return them to the factory. If you need further information or support concerning this notification, please contact your local Philips representative or call us at 1-800-722-9377. |
| Quantity | 2 units |
| Distribution | US Nationwide distribution in the state of MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063375 | HEARTSTART MRX, MODELS M3535A OR M3536A Philips Medical Systems, Jan 11, 2007 |