Philips Medical Systems Philips Medical HeartStart MRx Monitor/Defibrillator Model: M3535A, M3536A Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Philips Medical HeartStart MRx Monitor/Defibrillator Model: M3535A, M3536A
Brand
Philips Medical Systems
Lot Codes / Batch Numbers
Software Versions A.03.00 or lower and B.04.00 and lower
Products Sold
Software Versions A.03.00 or lower and B.04.00 and lower
Philips Medical Systems is recalling Philips Medical HeartStart MRx Monitor/Defibrillator Model: M3535A, M3536A due to The device may disarm and not deliver shock when performing a Synchronized Cardioversion. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The device may disarm and not deliver shock when performing a Synchronized Cardioversion
Recommended Action
Per FDA guidance
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.
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