Philips Medical Systems Philips Heartstart MRx Monitor/Defibrillator Models: M3535A (Hospital Use) , M3536A (EMS Use) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Philips Heartstart MRx Monitor/Defibrillator Models: M3535A (Hospital Use) , M3536A (EMS Use)
Brand
Philips Medical Systems
Lot Codes / Batch Numbers
Software versions A.02.00 and lower
Products Sold
Software versions A.02.00 and lower
Philips Medical Systems is recalling Philips Heartstart MRx Monitor/Defibrillator Models: M3535A (Hospital Use) , M3536A (EMS Use) due to 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 del. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026