FDA Medical Device Recalls (openFDA)
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 also perform synchronized cardioversion. Non-invasive external pacing is a device option. In AED mode, the HeartStart MRx allows the provider who is trained in Basic Life Support (BLS) to provide defibrillation therapy. The device analyzes a patient s rhythm and advises the user to deliver a shock. Voice prompts guide the user through the defibrillation process by providing instructions and patient information. The voice prompts are reinforced by messages that appear on the display. In both modes of operation, the HeartStart MRx utilizes impedance compensating biphasic truncated exponential therapy waveform. The HeartStart MRx can also be used for ECG monitoring of a patient using 3, 5 or 12 lead cables.
- Recall number
- Z-2488-2019
- Recalling firm
- Philips North America, LLC
- 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 also perform synchronized cardioversion. Non-invasive external pacing is a device option. In AED mode, the HeartStart MRx allows the provider who is trained in Basic Life Support (BLS) to provide defibrillation therapy. The device analyzes a patient s rhythm and advises the user to deliver a shock. Voice prompts guide the user through the defibrillation process by providing instructions and patient information. The voice prompts are reinforced by messages that appear on the display. In both modes of operation, the HeartStart MRx utilizes impedance compensating biphasic truncated exponential therapy waveform. The HeartStart MRx can also be used for ECG monitoring of a patient using 3, 5 or 12 lead cables.
- Status
- Terminated
- Initiated
- 2019-07-16
- Posted
- not on file
- Terminated
- 2022-10-20
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 2 units
- Distribution
- US Nationwide distribution in the state of MA.
- Lot, serial or model codes
- Lot/ Serial # US00539461, US00539462
- 510(k) numbers
- K063375
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28