Center Western
 
Friday, July 06, 2012
Philips HeartStart MRx Recall

"EMS GENERAL ANNOUNCEMENTS "

By: Erskine, Timothy
From the FDA:



Product Description
Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 Product Usage: The Heartstart MRx is for use 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 in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician

Recall Number
Z-1896-2012

Classification
Class II

Code Info
Manufactured between the dates of July 12, 2011 through September 2, 2011 and January 19, 2012 through May 22, 2012. Serial numbers within the ranges of: US00550047 to US00551654 and US00556357 to US00559493 respectively. There are also some additional MRx units that were repaired and may contain compromised components. These MRx unit serial numbers are identified below: US00210180, US00210183, US00210738, US00211000, US00213281 US00214706, US00316827, US00318163, US00319241, US00328491 US00329811, US00333101, US00536832, US00538140, US00543161 US00543825, US00544081, US00544214, US00546107, US00548046


Product Distributed Qty
2914 units

Reason For Recall
HeartStart MRx Unexpected Pads/Paddles ECG Failure




For full details, go to http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1896-2012&w=07052012


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