Recall Z-2337-2008 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Medical Systems
HeartStarMRtX Defibrillator/Monitor Models: M3535A/M3536A HeartStart MRx with a native 256Mbyte internal memory card with date code "0308. The product is used for the termination of ventricular tachycardia and ventricular fibrillation.
| Date | Sep 25, 2008 (initiated Jul 14, 2008) |
| Status | Terminated |
| Reason | Defective internal memory cards may exhibit one or more of the following behaviors: "Device repeatedly restarts approximately every 20 seconds "Slow device start-up of approximately 15 seconds or more. During this time, the MRx displays either a blank screen or the Philips HeartStart MRx Start-up screen prior to displaying the selected mode of operation (i.e. Monitor, AED, Pacing or Manual Defib mode). "Internal Memory Failure INOP message when attempting to print an event from the Data Management screen. "When printing from the Data Management screen, a patients Event Summary prints with so |
| Root cause | Nonconforming Material/Component |
| Action | Philips issued an Urgent Medical Device Correction notification on July 17, 2008. Customers in the US received their communication package via UPS. Letters to international customers mailed via a tracked method by local Philips representatives. Customers were informed on how to locate the serial number on their devices to determine whether or not they have affected units in their inventory. Customers are asked to follow the "Action To Be Taken By Customer/User" while they await , their correction. If users continue to use prior to correction, a back up defibrillator should be readily avail |
| Quantity | 523 units |
| Distribution | Nationwide Canada Australia, Brazil , China, France, Germany, Great Britain, Hong Kong, Indonesia, Italy,Latvia, New Zealand,Saudi Arabia, and South Africa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031187 | HEARTSTART MRX, MODEL M3535A Philips Medical Systems, Aug 27, 2003 |