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U.S. Department of Health and Human Services

Class 2 Device Recall Philips MRx Defibrillator

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  Class 2 Device Recall Philips MRx Defibrillator see related information
Date Initiated by Firm November 19, 2014
Date Posted January 13, 2015
Recall Status1 Terminated 3 on October 04, 2019
Recall Number Z-0963-2015
Recall Event ID 69747
510(K)Number K031187  K040404  K051134  K061707  K062233  K063375  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, 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.
Code Information Model M3535A: US00100100 to US00576623 Model M3536A: US00100902 to US00576650 Model M3536J: US00209838 to US00332675 Model M3536M: US00500002 to US00553553 Model M3536MC: US00500001 to US00500087 Model M3536M2: US00554176 to US00554178 Model M3536M4: US00500003 to US00574869 Model M3536M5: US00500001 to US00562935 Model M3536M6: US00554358 to US00576619 
Recalling Firm/
Manufacturer
Philips Medical Systems, Inc.
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
800-722-9377
Manufacturer Reason
for Recall
Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently.
FDA Determined
Cause 2
Software design
Action On November 19, 2014, Philips notified consignees of the recall via letter. The Urgent Medical Device Correction notification/Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. A software upgrade will be provided free of charge for all units affected by one or more of these issues. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrade. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice
Quantity in Commerce 74,499 devices
Distribution Worldwide Distribution - US Nationwide
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS
510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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