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U.S. Department of Health and Human Services

Class 2 Device Recall M4735A HeartStart XL Defibrillator/Monitor

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  Class 2 Device Recall M4735A HeartStart XL Defibrillator/Monitor see related information
Date Initiated by Firm April 13, 2020
Create Date May 20, 2020
Recall Status1 Terminated 3 on April 07, 2021
Recall Number Z-2053-2020
Recall Event ID 85147
510(K)Number K001725  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital 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. It must be used by or on the order of a physician.
Code Information All units. Product has been discontinued.
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 rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device may not turn on; 2) The device may not perform the selected function;3) The device may deliver a shock with an energy level different than the setting selected by the user. In any of these scenarios, appropriate therapy delivery may be delayed.
FDA Determined
Cause 2		 Process control
Action On April 13, 2020, the firm distributed URGENT Medical Device Recall letters to affected customers. Customers were informed of the device defect, which may result in the following unexpected behavior: - The device may not turn on. - The device may not perform the selected function. - The device may deliver a shock with an energy level different from the setting selected by the user. There have been three reported patient deaths potentially associated with the failure of the HeartStart XL Monitor/Defibrillator rotary therapy selector switch. Customers were advised that the HeartStart XL Defibrillator/Monitor has been discontinued and has reached its end of life. Therefore, custoemrs should replace and retire their units as soon as practically possible. Customers should continue to perform Shift Checks and Operational checks as recommended in the Instructions for Use (IFU) as this reduces the risk of a failure until your units are safely retired. If you identify a device that exhibits any of the behaviors described above, or which fails shift or operational checks, immediately remove it from service. Customers were asked to complete and fax or email the included customer reply form to Philips. If you need further information or support concerning this notification, please contact your local Philips representative or call us at 1-800-722-9377.
Quantity in Commerce 94,034 units
Distribution Worldwide distribution - US Nationwide 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 = AGILENT TECHNOLOGIES, INC.
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