FDA Medical Device Recalls (openFDA)
Philips Medical Systems, Inc.: 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.
- Recall number
- Z-0570-2014
- Recalling firm
- Philips Medical Systems, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2013-12-10
- Posted
- 2013-12-24
- Terminated
- 2017-04-18
- Reason
- MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 level falls below 7.6 mmHg
- Root cause
- Software design
- 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.
- Quantity
- 18,529 units
- Distribution
- US Nationwide and OUS.
- Lot, serial or model codes
- Software versions: F.02, R.02, 9.xx or any earlier versions Addendum Models: M3532A, M3535A, M3536AM, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 M3535A- HeartStart MRx Defibrillator Monitor M3536A- HeartStart MRx Defibrillator Monitor EtC02 Options A04 A05 A06 All M3532A Upgrade
- 510(k) numbers
- ["K051134"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28