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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare

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 Class 2 Recall
Philips Healthcare
see related information
Date Posted December 27, 2013
Recall Status1 Open
Recall Number Z-0593-2014
Recall Event ID 67052
Premarket Notification
510(K) Number
K051134 
Product Classification Automated External Defibrillators (Non-Wearable) - Product Code MKJ
Product Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart MRx ALS Monitor (Grey) 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
Code Information Serial numbers: US00558442 - US00558461 US00561519 US00558531 - US00558532 US00561578 US00558615 US00562454 US00558758 - US00558759 US00562504 - US00562527 US00560165 - US00560166 US00562640 - US00562641 US00560738 - US00560739 US00562832 US00560740 - US00560745 US00563125 US00560872 US00563231 - US00563243 US00560909 US00564032 US00561068 US00564177 US00561209 US00564409 US00561447 - US00561452 US00564793
Recalling Firm/
Manufacturer
Philips Medical Systems, Inc.
3000 Minuteman Rd
Andover, Massachusetts 01810-1032
Manufacturer Reason
for Recall
Error in the printing of the therapy energy setting labels on Philips HeartStart M3536A MRx Monitor/Defibrillators. The first energy setting is labeled 10 when it should be labeled1-10
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control
Action Philips sent a Customer Information Letter dated June 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. During an EI of the firm, the firm had not reported the correction to FDA. The Customer Information letter informs the customers what the behavior is and under what circumstances. The correction consisted of a replacement label that was provided free of charge to all units affected by this issue. Philips Healthcare representatives have been contact customers with affected devices to arrange for installation of the replacement label. To correct this issue, Philips will replace the label free of charge. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the replacement label. This issue does not affect current product shipments. I f you need any further information or support concerning this issue, please contact your local Philips representative at 1-800-722-9377. Philips apologizes for any inconvenience caused by this problem.
Quantity in Commerce 93 units
Distribution Worldwide Distribution - US Distribution including the states of IN, MS, TX and VA., and the countries of DENMARK, FRANCE, GERMANY, SPAIN and SWITZERLAND.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS
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