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U.S. Department of Health and Human Services

Class 2 Device Recall Philips QCPR Meter CPR feedback device

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  Class 2 Device Recall Philips QCPR Meter CPR feedback device see related information
Date Initiated by Firm January 29, 2018
Date Posted February 22, 2018
Recall Status1 Terminated 3 on May 05, 2020
Recall Number Z-0684-2018
Recall Event ID 79016
510(K)Number K051134  
Product Classification Aid, cardiopulmonary resuscitation - Product Code LIX
Product Philips QCPR Meter - used with MRx

Product Usage:
The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installed. The Q-CPR option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).
Code Information All QCPR meters and sensors in use with HeartStart MRx and FR3.  MODEL #(s): 861444, 861332, 989803139951, 989803162401, 989803149941
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
978-659-3000
Manufacturer Reason
for Recall		 Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform users of injuries associated with proper performance of CPR. As required by Consent Decree of Permanent Injunction No. 1:17-cv-11955-DJC, entered October 31, 2017 between United States of America and Philips North America
FDA Determined
Cause 2		 Device Design
Action Philips sent an Medical Device Recall letter dated January 19, 2018 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately return the attached reply card. For question contact your local Philips representative.
Quantity in Commerce 28094 in total
Distribution Worldwide Distribution - US Nationwide
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 = LIX and Original Applicant = PHILIPS MEDICAL SYSTEMS
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