Z-0963-2015Class II

HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2...

Name: Z-0963-2015 HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2...
Creator: Philips Medical Systems, Inc.
Published: 2014-11-19
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-11-19 / Terminated / root cause: software

FDA source

Philips Medical Systems, Inc. began a recall of HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart... on 2014-11-19. FDA classified it as Class II and gives the reason as "Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently". 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-0963-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-19
Posted: 2015-01-13
Terminated: 2019-10-04
Recalling firm: Philips North America LLC
Product: HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: 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.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently.
Root cause tag: software
FDA root cause: Software design
Action: On November 19, 2014, Philips notified consignees of the recall via letter. The Urgent Medical Device Correction notification/Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. A software upgrade will be provided free of charge for all units affected by one or more of these issues. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrade. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice
Quantity in commerce: 74,499 devices
Distribution: Worldwide Distribution - US Nationwide
Product codes and lots: Model M3535A: US00100100 to US00576623 Model M3536A: US00100902 to US00576650 Model M3536J: US00209838 to US00332675 Model M3536M: US00500002 to US00553553 Model M3536MC: US00500001 to US00500087 Model M3536M2: US00554176 to US00554178 Model M3536M4: US00500003 to US00574869 Model M3536M5: US00500001 to US00562935 Model M3536M6: US00554358 to US00576619

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0963-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0963-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-13

Product code MKJ

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)