Recall Z-2347-2012 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Healthcare Inc.
Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, 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,
| Date | Sep 10, 2012 (initiated Jun 20, 2012) |
| Status | Terminated |
| Reason | Therapy Cable Connection wear may lead to a malfunction in detection of defibrillation pads/paddles therapy Cables |
| Root cause | Equipment maintenance |
| Action | Philips notified customers on June 20, 2012, by an Urgent Medical Device Correction notification/Field Safety Notice and a revised Instructions for Use addendum for each HeartStart MRx unit. The Urgent Medical Device Correction notification/Field Safety Notice informs customers of the issue, identifies details of units affected and and identifies the action. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: Carefully read the attached HeartStart MRx Instructions for Use Addendum. |
| Quantity | 58,701 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of : 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 CROATIA (local name: Hrvatska |
| 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 |