Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician. The HeartStart MRx EtCO2 Option monitors carbon dioxide (CO2) and measures end-tidal carbon dioxide (EtCO2). The option provides an EtCO2 value and a CO2 waveform on the devices display.
FDA Recall Z-0570-2014 · Posted 2013-12-24
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Recalling FirmPhilips Medical Systems, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2013-12-10
Date Terminated2017-04-18
Product Quantity18,529 units
Reason for Recall
MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 level falls below 7.6 mmHg
Firm Action
Philips Healthcare issued an Customer Information letter dated February 20, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer with the addendum to the Instructions for Use.
If you have a ? in the parameter block and no CO2 waveform on the display, the waveform source is invalid. If invalid, check patient, confirm airway status and examine the FilterLine to make sure it is connected to the device and not kinked or pinched. For more information on the EtCO2 Option see
Monitoring Carbon Dioxide chapter in the HeartStart MRx Instructions for Use.
Should you have any questions or concerns, please contact your local Philips representative at 1-800-722-9377.
Root Cause
Software design
Distribution Pattern
US Nationwide and OUS.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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