Philips North America, LLC HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automatic mode (AED). In manual mode, the HeartStart MRx is a full featured manual defibrillator, designed for use by clinicians trained in Advanced Cardiac Life Support (ACLS). Manual operation allows users to select energy levels for external and internal defibrillation. Users may als Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automatic mode (AED). In manual mode, the HeartStart MRx is a full featured manual defibrillator, designed for use by clinicians trained in Advanced Cardiac Life Support (ACLS). Manual operation allows users to select energy levels for external and internal defibrillation. Users may als
Brand
Philips North America, LLC
Lot Codes / Batch Numbers
Lot/ Serial # US00539461, US00539462
Products Sold
Lot/ Serial # US00539461, US00539462
Philips North America, LLC is recalling HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightw due to Non-conforming devices are identified, which may not have been included in prior field actions and may not have had a number of corrections applicable. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Non-conforming devices are identified, which may not have been included in prior field actions and may not have had a number of corrections applicable to these devices.
Recommended Action
Per FDA guidance
1. Locate the MRx devices M3535A with the serial numbers US00539461 and US00539462. 2. Remove them from clinical use and quarantine these two devices in a secure location. 3. A Philips representative will contact you to arrange for the removal of the affected HeartStart MRx devices and return them to the factory. If you need further information or support concerning this notification, please contact your local Philips representative or call us at 1-800-722-9377.
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