Z-2488-2019Class II

HeartStart MRx Monitor/Defibrillator Model # M3535A -

Name: Z-2488-2019 HeartStart MRx Monitor/Defibrillator Model # M3535A -
Creator: Philips North America, LLC
Published: 2019-07-16
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2019-07-16 / Terminated

FDA source

Philips North America, LLC began a recall of HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes... on 2019-07-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2488-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-16
Posted: 2019-09-06
Terminated: 2022-10-20
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.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: 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.
FDA 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 in commerce: 2 units
Distribution: US Nationwide distribution in the state of MA.
Product codes and lots: Lot/ Serial # US00539461, US00539462

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2488-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2488-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-06

Product code MKJ

K063375Class IIIHeartstart Mrx, Models M3535a or M3536aPhilips Medical Systems / cleared 2007-01-11

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)