Recall Z-2293-2010 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Healthcare Inc.
HeartStart MRx Defibrillator/Monitor with Q-CPR Meter option.The HeartStart MRx monitor/defibrillator has an option (Q-CPR Meter) to provide visual and audible feedback to the rescuer on the quality of CPR. The Q-CPR option offers real time measurement and corrective feedback on the rate, depth and complete release of compressions, ventilations rate and lack of CPR activity in accordance with cur
| Date | Aug 27, 2010 (initiated May 6, 2010) |
| Status | Terminated |
| Reason | Reduced sensitivity in the force measurement sensor can result in inaccurate feedback to the user on how well he or she is releasing pressure after each chest compression. This can result in incomplete release of chest compression, which will reduce CPR effectiveness. |
| Root cause | Device Design |
| Action | Philips issued an "Urgent Medical Device Recall notification/Field Safety Notice" dated April 2010 to all consignees. The letter described the issue, how to identify affected devices, and required actions. The consignees were instructed to remove affected devices from service. Philips will contact consignees to arrange on-site replacement of affected meters with meters containing revised labeling and calibration software. The new meters will indicate that meter recalibration is required after approximately 50,000 compression cycles. Consignees returning devices to Philips for routine recalibra |
| Quantity | 72 units |
| Distribution | Worldwide distribution in the countries of USA, Canada, Australia, China, Germany, Iceland, India, Libyan Arab Jamahiri, Netherlands, Saudi Arabia, Spain, Switzerland, United Arab Emirates, and 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 |