Z-0341-05

Philips Heartstart MRx Monitor/Defibrillator Models: M3535A (Hospital Use) , M3536A (EMS Use)

Name: Z-0341-05 Philips Heartstart MRx Monitor/Defibrillator Models: M3535A (Hospital Use) , M3536A (EMS Use)
Creator: Philips Medical Systems
Published: 2004-12-15
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2004-12-15 / Terminated / root cause: software

FDA source

Philips Medical Systems began a recall of Philips Heartstart MRx Monitor/Defibrillator Models: M3535A (Hospital Use) , M3536A (EMS Use) on 2004-12-15. The reason FDA records is "In Software versions below A.02.00, with the sync function enabled and the device switched from manual to AED, there may be an unexpected delay in delivery of energy". 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-0341-05
Status: Terminated
Initiated: 2004-12-15
Posted: 2004-12-21
Terminated: 2016-02-02
Recalling firm: Philips North America LLC
Product: Philips Heartstart MRx Monitor/Defibrillator Models: M3535A (Hospital Use) , M3536A (EMS Use)
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: In Software versions below A.02.00, with the sync function enabled and the device switched from manual to AED, there may be an unexpected delay in delivery of energy
Root cause tag: software
FDA root cause: Other
Action: Philips notified customers on 12/13/04 by letter. Users are provided with action required to Mitigate Risk' until the correction is made by a Systems representative.
Quantity in commerce: 2520 units
Distribution: Nationwide Foreign:Canada, Austria, Australlia, Belgium, China, Denmark, Finland, France, Germany, Israel, Italy,Kuwait, Latvia, Lebannon, Libya, Netherland,Norway, Portugal, Qatar, Russia, Singapore,South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand,Tunisia, UK, United Arab Emirates, Yemen
Product codes and lots: Software versions A.02.00 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)