Recall Z-1986-2012 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Healthcare Inc.
Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the ord
| Date | Jul 11, 2012 (initiated Jun 20, 2012) |
| Status | Terminated |
| Reason | Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG |
| Root cause | Nonconforming Material/Component |
| Action | Philips Healthcare issued an Urgent Voluntary Medical Device Correction letter on June 20, 2012, to all affected customers. The Notification informs customers of the issue, identifies details (including models and software versions applicable) of units affected, instructions on actions to take while awaiting the correction, and identifies what action Philips plans to eliminate or remedy the issue A Philips Healthcare representative will contact customers to arrange for the updated R.03.03 software installation in all the affected devices. For questions customers were advised to call 1-800-72 |
| Quantity | 35 units |
| Distribution | Worldwide Distribution - USA including FL, IN, MA, M, NY, OH, TN, TX, and VA. Internationally to AUSTRALIA, HONG KONG, and INDIA |
| 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 |