Recall Z-0320-2016 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Electronics North America Corporation
Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibrillation.
| Date | Nov 20, 2015 (initiated Oct 14, 2015) |
| Status | Terminated |
| Reason | The following MRx software issue has been identified: MRx model M3535A with software version F.03.06 and earlier, and model M3536A with version T.00.05 and earlier may stop the automated Ready-For-Use (RFU) test in an abnormal state when the device is turned off. |
| Root cause | Software design |
| Action | On 10/14/2015, Philips sent an Urgent Field Safety Notice to each known affected customer. The Urgent Medical Device Correction notification/ Field Safety Notice 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. Philips will provide a software upgrade for M3535A (software version F.03.07 or higher) and M3536A (software version T.00.06 or higher) to correct this issue. A software upgrade will be provided free of charge for all affected product |
| Quantity | 81,161 |
| Distribution | Worldwide Distribution - US (nationwide) including Puerto Rico, and the countries of AFGHANISTAN, ALBANIA, ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA AND HERZEGOVINA, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CAMBODIA, CHILE, CHINA, COLOMBIA, COSTA RIC |
| 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 |