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U.S. Department of Health and Human Services

Class 2 Device Recall HeartStart MRx Defibrillator/Monitor with QCPRTM

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  Class 2 Device Recall HeartStart MRx Defibrillator/Monitor with QCPRTM see related information
Date Initiated by Firm May 06, 2010
Date Posted August 27, 2010
Recall Status1 Terminated 3 on February 19, 2013
Recall Number Z-2293-2010
Recall Event ID 55612
510(K)Number K051134  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact
978-687-1501
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS
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