Z-1499-2020Class II

HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3...

Name: Z-1499-2020 HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3...
Creator: Philips North America, LLC
Published: 2020-02-26
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2020-02-26 / Terminated / root cause: design

FDA source

Philips North America, LLC began a recall of HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and... on 2020-02-26. FDA classified it as Class II and gives the reason as "Philips has received a number of reports of HeartStart MRx Monitor/Defibrillators that have suffered internal damage and were not able to deliver therapy after having been dropped or subjected to a severe mechanical...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1499-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-26
Posted: 2020-03-13
Terminated: 2022-12-08
Recalling firm: Philips North America LLC
Product: HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Philips has received a number of reports of HeartStart MRx Monitor/Defibrillators that have suffered internal damage and were not able to deliver therapy after having been dropped or subjected to a severe mechanical shock, even though the device did not have visible external damage or the Ready for Use ( RFU ) indicator on the unit did not immediately indicate a problem. One of these reports involved a death of a patient who could not be resuscitated.
Root cause tag: design
FDA root cause: Device Design
Action: On February 26, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that if the device is dropped or subjected to a severe mechanical shock, it may suffer internal damage even in the absence of visible external damage or the Ready for Use indicator unit does not immediately indicate a problem. Customers were instructed to inform all users that if the device is dropped or subjected to severe mechanical shock and the exterior case is still intact, they should immediately perform an operational check as described in the IFU section "Performing the Operational Check" in the Maintenance Chapter. The unit should be taken out of service and Philips Customer Service contacted if the unit is visibly damaged or if the device fails the operational check, i.e., if the RFU indicator changes to a red-X or the device emits a periodic audible chirp, as described in the IFU. Customers were instructed to insert a copy of the customer notice into each copy of the HeartStart MRx IFU. If you need further information or support concerning this notification, please contact your local Philips representative or call the firm at 1-800-722-9377.
Quantity in commerce: 97788 units
Distribution: US Nationwide domestic distribution. Worldwide foreign distribution.
Product codes and lots: All units are affected by this recall

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1499-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1499-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-13

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)