Recall Z-1618-2010 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Healthcare Inc.
HeartStart MRx Defibrillator Monitor, Model M3535A HeartStart MRx Defibrillator Monitor, Model M3536A 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 m
| Date | May 24, 2010 (initiated Apr 7, 2010) |
| Status | Terminated |
| Reason | ECG signal processing chip may fail causing failure to deliver therapy in AED mode or the failure to indicate poor electrical contact (very high impedance) with the patient in Manual Defib mode. |
| Root cause | Component design/selection |
| Action | The firm, Philips Healthcare, sent an "URGENT voluntary Medical Device Correction" Field Safety Notice, letter dated April 7, 2009, to all customers via UPS. The letter describes the product, problem and the actions to be taken by customers, with precautions to follow if the device is used before upgrade is installed. The customers were instructed to check their serial numbers for the affected product, if the device is affected, it may remain in service prior to correction using the following precautions 1) if using AED, have a back up AED; 2) if using external defibrillator paddles, disregar |
| Quantity | 1379 units |
| Distribution | Worldwide distribution:USA and Canada, Argentina, Australia, Austria, Belgium, Brazil, China, Finland, France, Germany, Iceland, India, Ireland, Italy, Japan, Korea, Republic of Lithuania, Mexico, Netherlands, New Zealand, Norway, Poland, South Africa, Spain, Switzerland, Thailand, Trinidad, and Tob |
| 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 |