Z-0684-2018Class II

Philips QCPR Meter - used with MRx

Name: Z-0684-2018 Philips QCPR Meter - used with MRx
Creator: Philips Electronics North America Corporation
Published: 2018-01-29
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2018-01-29 / Terminated / root cause: design

FDA source

Philips Electronics North America Corporation began a recall of Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators... on 2018-01-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0684-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-29
Posted: 2018-02-22
Terminated: 2020-05-05
Recalling firm: Philips North America LLC
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).
Product code: LIX Aid, Cardiopulmonary Resuscitation
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
Root cause tag: design
FDA 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 in commerce: 28094 in total
Distribution: Worldwide Distribution - US Nationwide
Product codes and lots: All QCPR meters and sensors in use with HeartStart MRx and FR3. MODEL #(s): 861444, 861332, 989803139951, 989803162401, 989803149941

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0684-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0683-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-22
Z-0684-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-22

Product code LIX

K051134Class IIIHeartstart Mrx with Q-CPR Option, Models M3535a or M3536aPhilips Medical Systems / cleared 2005-09-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)