Class 2 Device Recall HeartStart MRx

• Date Initiated by Firm: February 26, 2020
• Create Date: March 13, 2020
• Recall Status: Terminated on December 08, 2022
• Recall Number: Z-1499-2020
• Recall Event ID: 84841
• 510(K)Number: K063375
• Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ
• Product: HeartStart MRx Monitor/Defibrillators with model numbers M3535A; M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, ; M3536M6, M3536M7, M3536M8, and M3536M9.
• Code Information: All units are affected by this recall
• Recalling Firm/ Manufacturer: Philips North America, LLC; 3000 Minuteman Rd; Andover MA 01810-1032
• For Additional Information Contact: Philips Customer Services; 978-659-3000
• Manufacturer Reason for Recall: Philips has received a number of reports of HeartStart MRx Monitor/Defibrillators that have suffered internal damage and were not able to deliver therapy after having been dropped or subjected to a severe mechanical shock, even though the device did not have visible external damage or the Ready for Use ( RFU ) indicator on the unit did not immediately indicate a problem. One of these reports involved a death of a patient who could not be resuscitated.
• FDA Determined Cause: Device Design
• Action: On February 26, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that if the device is dropped or subjected to a severe mechanical shock, it may suffer internal damage even in the absence of visible external damage or the Ready for Use indicator unit does not immediately indicate a problem. Customers were instructed to inform all users that if the device is dropped or subjected to severe mechanical shock and the exterior case is still intact, they should immediately perform an operational check as described in the IFU section "Performing the Operational Check" in the Maintenance Chapter. The unit should be taken out of service and Philips Customer Service contacted if the unit is visibly damaged or if the device fails the operational check, i.e., if the RFU indicator changes to a red-X or the device emits a periodic audible chirp , as described in the IFU. Customers were instructed to insert a copy of the customer notice into each copy of the HeartStart MRx IFU. If you need further information or support concerning this notification, please contact your local Philips representative or call the firm at 1-800-722-9377.
• Quantity in Commerce: 97788 units
• Distribution: US Nationwide domestic distribution. Worldwide foreign distribution.
• 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