Class 2 Device Recall Philips HeartStart MRx

• Date Initiated by Firm: July 16, 2020
• Create Date: August 13, 2020
• Recall Status: Terminated on August 03, 2021
• Recall Number: Z-2794-2020
• Recall Event ID: 85743
• 510(K)Number: K031187
• Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ
• Product: Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 - Product Usage: is intended for use in hospital and pre-hospital settings by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support or defibrillation.
• Code Information: All devices are affected
• FEI Number: 1218950
• Recalling Firm/ Manufacturer: Philips North America, LLC; 3000 Minuteman Rd; Andover MA 01810-1032
• For Additional Information Contact: Philips Customer Services; 800-722-9377
• Manufacturer Reason for Recall: The therapy switch may fail, resulting in the device exhibiting the following behaviors: the device may not perform the selected function, the therapy knob may not change to the energy setting selected, or the device may deliver a shock with an energy level different from the setting selected by the user. These device behaviors could result in a delay in therapy or a failure to deliver the intended therapy.
• FDA Determined Cause: Process control
• Action: On July 16, 2020, the firm distributed an Urgent Medical Device Correction letter to all affected customers. Customers were informed of the product issue and were instructed to do the following: - The MRx is safe to use and can remain in service if the device does not exhibit any of the behaviors described in this Notice (the device may not perform the selected function, the therapy knob may not change to the energy setting selected, or the device may deliver a shock with an energy level different from the setting selected by the user.) - If an MRx device experiences a switch failure as described, contact your local Philips representative, who can arrange for a replacement of the switch at no charge. - Continue to perform the Shift and Operational Checks described in the Instructions for Use, Maintenance Chapter - To detect possible switch failures as early as possible, conduct Weekly Shock Tests (part of the Shift Check in the IFU) on a daily basis - It is not necessary to perform a Shock Test on days when an Operational Check is performed, since an Operational Check includes a Shock Test. - Keep a copy of the customer letter with each HeartStart MRx Instructions for Use. - To acknowledge receipt of this notification, please complete and fax the Customer Reply Form to the firm. If the MRx Therapy Switch fails, Philips will arrange for the replacement of the switch at no charge to the customer.
• Quantity in Commerce: 95,212 units
• Distribution: Worldwide 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