Recall Z-2842-2016 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Electronics North America Corporation
HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A
| Date | Aug 26, 2016 |
| Status | Terminated |
| Reason | The handle can separate from the MRx housing due to breakage of mounts on the rear case. |
| Root cause | Device Design |
| Action | Philips Healthcare issued customer an Urgent Medical Device Correction notification/Field Safety Notice on 11/19/14. The Urgent Medical Device Correction notification/Field Safety Notice FSN86100158A informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer, and identifies what action Philips plans to take to remedy the issue. You can continue to use your MRx prior to receiving the hardware upgrade. If one or both sides of the handle are found to have separated from the MRx housing, continue to treat your patient per |
| Quantity | 394 units |
| Distribution | Worldwide distribution. US Nationwide, Canada, AUSTRALIA, FRANCE, GERMANY, INDIA, JAPAN, NETHERLANDS, SOUTH AFRICA, SPAIN, SWEDEN, THAILAND, and UNITED KINGDOM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031187 | HEARTSTART MRX, MODEL M3535A Philips Medical Systems, Aug 27, 2003 |
| K040404 | HEARTSTART MRX, MODEL M3535A Philips Medical Systems, Inc., May 4, 2004 |
| K051134 | HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A Philips Medical Systems, Sep 8, 2005 |
| K061707 | HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS Philips Medical Systems, Aug 11, 2006 |
| K062233 | HEARTSTART MRX MONITOR/DEFIBRILLATOR Philips Medical Systems North America, Inc., Nov 22, 2006 |