Recall Z-1795-2009 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Healthcare Inc.
HeartStart MRx/MRxE Defibrillator/Monitor Models: M3536A (HeartStart MRx) and M3536J (HeartStart MRxE). Note: M3536JIMRxE was sold to Japan only. The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automatic mode (AED).
| Date | Jul 24, 2009 (initiated Jul 7, 2009) |
| Status | Terminated |
| Reason | External transport use environments, the mechanical/electrical connection between the pads therapy cable including pads/CPR cable and the MRx/MRxE may wear at an increased rate ultimately prevent the device from sensing that the pads therapy cable is connected, or, cause the device to inappropriately identify external paddles or internal paddles when the pads therapy cable is connected |
| Root cause | Device Design |
| Action | Philips Healthcare issued an "Urgent - Voluntary Medical Device Correction" notice dated July 2009 providing information on the affected device, namely, how to identify the affected devices and instructions on actions to be taken. Consignees are asked to contact their local Philips representative to confirm receipt of the recall letter and to arrange for service. Contact Philips Healthcare for further questions at 1-800-722-9377. |
| Quantity | 11,579 units |
| Distribution | Worldwide Distribution -- United States, Afghanistan, Albania, Australia, Austria, Bahrain, Brazil, China, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libyan Arab Ja |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031187 | HEARTSTART MRX, MODEL M3535A Philips Medical Systems, Aug 27, 2003 |