Recall Z-0613-2014 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 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 de
| Date | Dec 31, 2013 (initiated Apr 10, 2013) |
| Status | Terminated |
| Reason | Device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of electromagnetic interference from other radio frequency (RF) energy sources and |
| Root cause | Environmental control |
| Action | Philips issued a Medical Device Correction letter April 2013 to all affected customers along with an IFU Addendum titled, HeartStart MRx Electromagnetic Compatibility. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that the condition could be avoided by operating the device on external AC or external DC power. Customers were instructed to follow the device instructions when using battery power to minimize or eliminate potential interference from other RF sources. Customers with questions were instructed to contact the |
| Quantity | 64,972 |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to the following countries: AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND HERZEGOWINA BRAZIL BRUNEI DARUSSALAM BULGARIA CAMBODIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROAT |
| 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 |