Class 1 Device Recall HeartStart MRx Monitor/Defibrillator

• Date Initiated by Firm: July 12, 2017
• Date Posted: February 08, 2018
• Recall Status: Terminated 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/ Manufacturer: Philips North America, LLC; 3000 Minuteman Rd; Andover MA 01810-1032
• For Additional Information Contact: Thomas Fallon; 978-659-3000
• 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: 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.