Z-1612-2016Class II

HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular...

Name: Z-1612-2016 HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular...
Creator: Philips Electronics North America Corporation
Published: 2016-04-14
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2016-04-14 / Terminated / root cause: manufacturing process

FDA source

Philips Electronics North America Corporation began a recall of HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is... on 2016-04-14. FDA classified it as Class II and gives the reason as "MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component". 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-1612-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-14
Posted: 2016-06-02
Terminated: 2019-03-27
Recalling firm: Philips North America LLC
Product: HeartStart MRx Monitor/Defibrillator 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: MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Philips Healthcare sent an Urgent Medical Device Correction letter dated April 2016, on April 14, 2016, to all affected customers. The letter informed customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The correction will consist of providing a replacement MRx unit, free of charge, for all units affected by this issue. When the replacement unit arrives, please use the return shipping label and packaging provided with the replacement MRx unit to return the affected unit to Philips. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: You can continue to use your MRx prior to receiving a replacement unit. But, if you observe a red X in the Ready for Use (RFU) indicator, you should follow the troubleshooting instructions in the MRx IFU. Customers with questions were instructed to contact their local Philips representative or call 1-800-722-9377.
Quantity in commerce: 17
Distribution: Worldwide Distribution - US including OH, CA, NC and Internationally to China, Iraq, Japan, and Korea.
Product codes and lots: US00586611, US00589878, US00594232, US00588464, US00591080, US00594779, US00588657, US00592182, US00594913, US00589391, US00593861, US00595298, US00589472, US00594092, US00595443, US00589851, US00594168

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1612-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1612-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-11	2016-05-05

Product code MKJ

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)