Recall Z-1797-2013 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Healthcare Inc.
Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
| Date | Jul 24, 2013 (initiated Jun 19, 2013) |
| Status | Terminated |
| Reason | The MRx may deliver a non-synchronized cardioversion shock resulting in the delivery of incorrect therapy, which may induce ventricular fibrillation. |
| Root cause | Software design |
| Action | Philips sent an Urgent Medical Device Correction letter on June 19, 2013, to all affected customers. The letter informed customers of the issue, identified details of the units affected, gave instructions on actions to be taken by the customer and identified what action Philips planned to take to remedy the issue. Philips will perform a software upgrade and replace the label on the unit that outlines the steps for Synchronized Cardioversion with a revised label for all affected units at no charge to the customer. Philips is asking customers to follow the Action to be Taken by Customer/User |
| Quantity | 66,150 units |
| Distribution | Worldwide Distribution - USA (nationwide) and 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 CZEC |
| 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 |