Z-2035-2018Class II

HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external...

Name: Z-2035-2018 HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external...
Creator: Philips Electronics North America Corporation
Published: 2018-05-03
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2018-05-03 / Terminated / root cause: manufacturing process

FDA source

Philips Electronics North America Corporation began a recall of HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) Product Usage: The... on 2018-05-03. FDA classified it as Class II and gives the reason as "The MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component. Failure to charge could potentially cause therapy to be...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2035-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-03
Posted: 2018-05-30
Terminated: 2019-10-17
Recalling firm: Philips North America LLC
Product: HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: The MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component. Failure to charge could potentially cause therapy to be interrupted or delayed.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On May 3, 2018, the firm issued an Urgent Amended Medical Device Correction notice to affected customers via certified mail. Customers were reminded that they were previously notified in April 2016 regarding the same issue. At that time, the firm committed to providing a replacement for all affected MRx units. The May 2018 notification was sent only to remaining customers who had not yet received a replacement device. Those customers were informed that due to the product being discontinued, their affected units would receive a replacement therapy board instead of a replacement unit. Customers were informed that they could continue to use their MRx prior to repair. But, if they observe a red X in the Ready for Use indicator, to follow the troubleshooting instructions in the MRx IFU. They were also advised that they would be contacted by Philips to schedule the repair of the device. If the customer has already returned their unit but has not yet received a replacement, they were advised that Philips will be replacing the therapy board, not the entire device. 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: 5
Distribution: Worldwide Distribution to accounts in OH and NC. Foreign distribution to Lebanon.
Product codes and lots: US00588464, US00588657, US00589878, US00591080, US00593861

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2035-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2035-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)