Recall Z-2157-2020 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips North America, LLC
Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation.
| Date | Apr 27, 2020 |
| Status | Terminated |
| Reason | HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections |
| Root cause | Process change control |
| Action | Philips Issued Urgent Medical Device Removal Letter (FSN86100214) on 4/27/20 via Certified Mail to U.S. customers, via certified mail. Philips Markets Organizations are responsible for distributing the letters outside of the U.S. Letter states reason for recall, health risk, action to take: Upon receipt of this notification, promptly locate the affected MRx M3535A, M3536A, and M3536M devices remove them from clinical use immediately. A Philips representative will contact you to arrange removal of the affected devices for evaluation. If you need further information or support concerning this |
| Quantity | 260 units |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of China, Republic of Korea, Netherlands, Norway, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051134 | HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A Philips Medical Systems, Sep 8, 2005 |