Recall Z-1390-2009 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Healthcare Inc.
HeartStart MRx Defibrillator/Monitor, M3535A/M3536A Is used for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
| Date | Jun 2, 2009 (initiated Apr 10, 2009) |
| Status | Terminated |
| Reason | Spontaneous turn-on which could deplete the battery, rendering the device unusable until power is restored. There is also the possibility of a failure mode in which the device fails to respond to user initiated turn-on, rendering it unusable for monitoring and therapy. |
| Root cause | Nonconforming Material/Component |
| Action | Philips notified customers via Urgent Medical Device Recall Letter & Notice dated March 2009. Customers are asked to follow the "Actions to be taken by customer/user section of the Urgent Medical Device Recall Notice. In this section, customers are given the following instructions: "During the interim period, as you await the upgrade for your device, you may continue to use the Heartstart MRx. However, to reduce the risk that a spontaneous turn-on could deplete the battery, it is advised that you keep: a charged spare battery with the Heartstart MRx AC power applied, if possible, when the d |
| Quantity | 12,385 units US; 9,791 units OUS |
| Distribution | Worldwide Distribution -- USA, Canada, Afghanistan, Argentina, Aruba, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Iceland, India, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.