BEUDAMED
    FDA Recall Terminated

    Philips QCPR Meter - used with FR3 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).

    Recall: Z-0683-2018 · Initiated January 29, 2018

    Recall

    Recall Number
    Z-0683-2018
    Event Number
    79016
    Firm
    Philips Electronics North America Corporation
    FEI Number
    1218950
    Product Code
    LIX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 29, 2018
    Posted
    February 22, 2018
    Terminated
    May 5, 2020
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Philips QCPR Meter - used with FR3 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).

    Reason

    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

    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.

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    28094 in total