Recall Z-1110-2014 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC
| Date | Feb 26, 2014 (initiated Feb 4, 2014) |
| Status | Terminated |
| Reason | HeartStart MRx Defibrillator Monitor therapy connection could experience accelerated wear causing risk for patients and/or caregivers |
| Root cause | Device Design |
| Action | Philips Medical North America issued on 2/4/14 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. The correction will consist of free of charge service support for the MRx therapy connection, including inspection of therapy connection, and installation of a stabilizing collar if not already present. If wear is detected, therapy components (including therapy pads/cables, CPR t |
| Quantity | 58466 units |
| Distribution | Worldwide Distribution: USA (nationwide) and to countries of: AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND HERZEGOWINA BRAZIL BRUNEI DARUSSALAM BULGARIA CAMBODIA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZ |
| 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 |