Z-2293-2010

HeartStart MRx Defibrillator/Monitor with Q-CPR Meter option.The HeartStart MRx monitor/defibrillator has an...

Name: Z-2293-2010 HeartStart MRx Defibrillator/Monitor with Q-CPR Meter option.The HeartStart MRx monitor/defibrillator has an...
Creator: Philips Healthcare Inc.
Published: 2010-05-06
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2010-05-06 / Terminated / root cause: design

FDA source

Philips Healthcare Inc. began a recall of HeartStart MRx Defibrillator/Monitor with Q-CPR Meter option.The HeartStart MRx monitor/defibrillator has an option (Q-CPR Meter) to provide visual and audible... on 2010-05-06. The reason FDA records is "Reduced sensitivity in the force measurement sensor can result in inaccurate feedback to the user on how well he or she is releasing pressure after each chest compression. This can result in incomplete release of chest...". 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-2293-2010
Status: Terminated
Initiated: 2010-05-06
Posted: 2010-08-27
Terminated: 2013-02-19
Recalling firm: Philips North America LLC
Product: HeartStart MRx Defibrillator/Monitor with Q-CPR Meter option.The HeartStart MRx monitor/defibrillator has an option (Q-CPR Meter) to provide visual and audible feedback to the rescuer on the quality of CPR. The Q-CPR option offers real time measurement and corrective feedback on the rate, depth and complete release of compressions, ventilations rate and lack of CPR activity in accordance with current CPR guidelines. The Q-CPR option is contraindicated as follows: *The Q-CPR option is contraindicated for use on neonatal and pediatric patients (under 8 years of age or weighing less than 25 kg). *The Q-CPR option is not for use when CPR is contraindicated.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Reduced sensitivity in the force measurement sensor can result in inaccurate feedback to the user on how well he or she is releasing pressure after each chest compression. This can result in incomplete release of chest compression, which will reduce CPR effectiveness.
Root cause tag: design
FDA root cause: Device Design
Action: Philips issued an "Urgent Medical Device Recall notification/Field Safety Notice" dated April 2010 to all consignees. The letter described the issue, how to identify affected devices, and required actions. The consignees were instructed to remove affected devices from service. Philips will contact consignees to arrange on-site replacement of affected meters with meters containing revised labeling and calibration software. The new meters will indicate that meter recalibration is required after approximately 50,000 compression cycles. Consignees returning devices to Philips for routine recalibration will receive free replacement. All CPR meters will be replaced with re-designed meters when they become available. For questions or assistance in notifying accounts about this recall, contact Philips at 1-800-722-9377.
Quantity in commerce: 72 units
Distribution: Worldwide distribution in the countries of USA, Canada, Australia, China, Germany, Iceland, India, Libyan Arab Jamahiri, Netherlands, Saudi Arabia, Spain, Switzerland, United Arab Emirates, and United Kingdom.
Product codes and lots: M3535A/M3536A HeartStart MRx 453564145481 MRx Q-CPR meter 861444, MRx Q-CPR Meter Upgrade 989803162401, MRx Replacement Q-CPR Meter. Lot numbers on distribution list.

Product code MKJ

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)