Z-1986-2012Class II

Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for...

Name: Z-1986-2012 Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for...
Creator: Philips Healthcare Inc.
Published: 2012-06-20
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-06-20 / Terminated / root cause: manufacturing process

FDA source

Philips Healthcare Inc. began a recall of Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termination of ventricular tachycardia and... on 2012-06-20. FDA classified it as Class II and gives the reason as "Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1986-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-20
Posted: 2012-07-11
Terminated: 2013-08-14
Recalling firm: Philips North America LLC
Product: Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 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: Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Philips Healthcare issued an Urgent Voluntary Medical Device Correction letter on June 20, 2012, to all affected customers. The Notification informs customers of the issue, identifies details (including models and software versions applicable) of units affected, instructions on actions to take while awaiting the correction, and identifies what action Philips plans to eliminate or remedy the issue A Philips Healthcare representative will contact customers to arrange for the updated R.03.03 software installation in all the affected devices. For questions customers were advised to call 1-800-722-9377. For questions regarding this recall call 978-687-1501.
Quantity in commerce: 35 units
Distribution: Worldwide Distribution - USA including FL, IN, MA, M, NY, OH, TN, TX, and VA. Internationally to AUSTRALIA, HONG KONG, and INDIA
Product codes and lots: Serial Numbers: US00558452, US00558453, US00558493, US00558494, US00558539 US00558540, US00558546, US00558547, US00558569, US00558576 US00558584, US00558595, US00558596, US00558597, US00558615 US00558617, US00558618, US00558619, US00558620, US00558621 US00558625, US00558626, US00558627, US00558628, US00558629 US00558630, US00558640, US00558641, US00558642, US00558643 US00558644, US00558779, US00558780, US00558950, US00558952

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1986-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1986-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-11

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