Z-0570-2014Class II

Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the...

Name: Z-0570-2014 Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the...
Creator: Philips Medical Systems, Inc.
Published: 2013-12-10
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2013-12-10 / Terminated / root cause: software

FDA source

Philips Medical Systems, Inc. began a recall of Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the termination of ventricular tachycardia and... on 2013-12-10. FDA classified it as Class II and gives the reason as "MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 level falls below 7.6 mmHg". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0570-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-10
Posted: 2013-12-24
Terminated: 2017-04-18
Recalling firm: Philips North America LLC
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.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 level falls below 7.6 mmHg
Root cause tag: software
FDA 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 in commerce: 18,529 units
Distribution: US Nationwide and OUS.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0570-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0570-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-24

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)