FDA Medical Device Recalls (openFDA)
Philips Electronics North America Corporation: 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).
- Recall number
- Z-0684-2018
- Recalling firm
- Philips Electronics North America Corporation
- 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).
- Status
- Terminated
- Initiated
- 2018-01-29
- Posted
- 2018-02-22
- Terminated
- 2020-05-05
- 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
- Root cause
- 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
- 28094 in total
- Distribution
- Worldwide Distribution - US Nationwide
- Lot, serial or model codes
- All QCPR meters and sensors in use with HeartStart MRx and FR3. MODEL #(s): 861444, 861332, 989803139951, 989803162401, 989803149941
- 510(k) numbers
- ["K051134"]
- PMA numbers
- not on file
- Product code
- LIX
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28