Z-0003-2010

HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE is for use for the termination...

Name: Z-0003-2010 HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE is for use for the termination...
Creator: Philips Healthcare Inc.
Published: 2009-08-21
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2009-08-21 / Terminated

FDA source

Philips Healthcare Inc. began a recall of HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE is for use for the termination of ventricular tachycardia and ventricular... on 2009-08-21. The reason FDA records is "incorrect default configuration settings, insufficient battery power as the user may not be alerted that no battery is installed or that a low battery condition exists prior to disconnecting from AC or DC power". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0003-2010
Status: Terminated
Initiated: 2009-08-21
Posted: 2009-11-09
Terminated: 2017-04-25
Recalling firm: Philips North America LLC
Product: HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE 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 basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: incorrect default configuration settings, insufficient battery power as the user may not be alerted that no battery is installed or that a low battery condition exists prior to disconnecting from AC or DC power
FDA root cause: Process change control
Action: Philips Healthcare issued a Urgent Voluntary Medical Device Correction Notification on August 21, 2009 advising users of the problem and Customers are asked to follow the "Action to be taken by customer/user" section of the Urgent Voluntary Medical Device Correction Notification. In this section, customers are given the instructions to correct their devices. For further information or support concerning this issue, please contact Philips representative at 1-800-722-9377.
Quantity in commerce: 1,523 units
Distribution: Nationwide Canada Australia, Austria, Beharin, BRUNEI DARUSSALAM,Chian,. Finland, France, Germany,Hong Kong, India, Indonesia, Ireland, Israel,Italy, Japan, Libya, Lithuania. Mexico, Nambia, Netherlands, Palestine, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, UAE, UK
Product codes and lots: Serial numbers within the following range. US00533518 through US00535118.

Product code MKJ

K031187Class IIIHeartstart Mrx, Model M3535aPhilips Medical Systems / cleared 2003-08-27

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)