Z-0848-05

Philips Medical HeartStart MRx Monitor/Defibrillator Model: M3535A, M3536A

Name: Z-0848-05 Philips Medical HeartStart MRx Monitor/Defibrillator Model: M3535A, M3536A
Creator: Philips Medical Systems
Published: 2005-04-29
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2005-04-29 / Terminated / root cause: software

FDA source

Philips Medical Systems began a recall of Philips Medical HeartStart MRx Monitor/Defibrillator Model: M3535A, M3536A on 2005-04-29. The reason FDA records is "The device may disarm and not deliver shock when performing a Synchronized Cardioversion". 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-0848-05
Status: Terminated
Initiated: 2005-04-29
Posted: 2005-05-17
Terminated: 2010-09-14
Recalling firm: Philips North America LLC
Product: Philips Medical HeartStart MRx Monitor/Defibrillator Model: M3535A, M3536A
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: The device may disarm and not deliver shock when performing a Synchronized Cardioversion
Root cause tag: software
FDA root cause: Software design
Action: Philips Medical Systems notified accounts by letter on 5/2/05. The firm provided instructions for identifying the effected devices and actions to be taken until the software is availablel for installation.
Quantity in commerce: 5125 units
Distribution: Nationwide Foreign: Canada, Austria, Australia Bahrain, Belgium, Brazil, China, Hong Kong, India, Finland,France, Germany, Hungry, Israel, Italy, Korea, Kuwait, Latvia, Lebanon, Mexico, Namibia, Libya, Netherland, New Zealnd, Norway, Oma, Philippines, Portugal, Qatat, Russia, South Africa, Singapore Spain, Sweden, Switzerland, Tawian, Thailand, Tunisia, UK, United Arab Emirates, Yemen
Product codes and lots: Software Versions A.03.00 or lower and B.04.00 and lower

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)