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.

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 some clinical events missing.

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 available. Devices that exhibit repeated restart or slow start -up should be removed from service. The correction will come in the form of an internal memory card replacement. Philips will contact customers to arrange for the correction of their devices. Contact Philips Medical at 1-978-687-1501 for assistance.