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

FDA device recall Z-2293-2010 · posted 2010-08-27 · Terminated

Recall details

Recalling firm

Philips Healthcare Inc.

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

MKJ

Quantity affected

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

Date initiated

2010-05-06

Date posted

2010-08-27

Date terminated

2013-02-19

Location

Andover, MA

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