Events

Recall of Device Recall Philips QCPR Meter CPR feedback device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Electronics North America Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79016
  • Event Risk Class
    Class 2
  • Event Number
    Z-0683-2018
  • Event Initiated Date
    2018-01-29
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161173
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Aid, cardiopulmonary resuscitation - Product Code LIX
  • 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.

Device

Device Recall Philips QCPR Meter CPR feedback device
  • Model / Serial
    All QCPR meters and sensors in use with HeartStart MRx and FR3.  MODEL #(s): 861444, 861332, 989803139951, 989803162401, 989803149941
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide
  • Product Description
    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).
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Manufacturer Address
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA