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U.S. Department of Health and Human Services

Class 1 Device Recall HeartStart MRx Monitor/Defibrillator

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  Class 1 Device Recall HeartStart MRx Monitor/Defibrillator see related information
Date Initiated by Firm July 12, 2017
Date Posted February 08, 2018
Recall Status1 Terminated 3 on May 27, 2020
Recall Number Z-0489-2018
Recall Event ID 78351
510(K)Number K031187  K040404  K051134  K061707  K062233  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969

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 Serial Numbers:  US00601802, US00601968, US00601969, US00602114, US00602122, US00602124, US00602125, US00602126, US00602127, US00602128, US00602145, US00602180, US00602182, US00602184, US00602185, US00602186, US00602187, US00602189, US00602206, US00602236, US00602237, US00602238, US00602239, US00602240, US00602241, US00602242, US00602243, US00602244, US00602245, US00602246, US00602247, US00602248, US00602250, US00602251, US00602252, US00602253, US00602254, US00602344, US00602345, US00602346, US00602347, US00602348, US00602349, US00602350, US00602351, US00602352, US00602353, US00602354, US00602355, US00602356, US00602357, US00602358, US00602359, US00602360, US00602361, US00602362, US00602363, US00602364, US00602365, US00602366, US00602367, US00602368, US00602369, US00602370, US00602371, US00602372, US00602373, US00602374, US00602375, US00602376, US00602377
Recalling Firm/
Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Thomas Fallon
Manufacturer Reason
for Recall
Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also prevent delivery of shocks in AED mode.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Philips Healthcare sent an Urgent Medical Device Correction Notification/Field Safety Notice letter dated June, 2017 to their customers. The letter identified the affected product, problem, hazard involved and actions to be taken. Philips is requesting that customers report if their device fails to function as intended. Philips will contact all customers for device replacement once parts are available. If you need further information or support concerning this action, please contact your local Philips representative.
Quantity in Commerce 71 units
Distribution No U.S. distribution, Internationally to: India, Ireland, Japan, Republic of Korea, Malaysia, Mexico, South Africa & United Kingdom
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.