Recall Z-1155-2014 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491
| Date | Mar 7, 2014 (initiated Feb 18, 2014) |
| Status | Terminated |
| Reason | MRx may display a Red X in the Ready For Use (RFU) indicator during automated tests informing the user that a failure has been detected that may prevent the delivery of a shock and pacing |
| Root cause | Component design/selection |
| Action | Philips Healthcare issued and Urgent Medical Device Correction notification/Field Safety Notice on 02/18/14 to inform customers of the issue, 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: You can continue to use your MRx prior to receiving the hardware upgrade, provided that if you observe that the MRx is displaying a Red X in the Ready For Use (RFU) indicator\during automated tests, a failure has been detected that may prevent the delivery of a shock or pacing due to this issu |
| Quantity | 3541 units |
| Distribution | Nationwide Foreign: AUSTRIA BAHRAIN BELGIUM BRAZIL CANADA CHINA EGYPT ESTONIA FINLAND FRANCE GERMANY GHANA ICELAND INDIA INDONESIA IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KOREA, REPUBLIC OF LATVIA LEBANON LIBYAN ARAB JAMAHIRIYA LITHUANIA MALAYSIA MEXICO MOZAMBIQUE MYANMAR (Burma) NETHERLANDS NETHERL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.