FDA Medical Device Recalls (openFDA)
Philips Electronics North America Corporation: 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.
- Recall number
- Z-1612-2016
- Recalling firm
- Philips Electronics North America Corporation
- 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.
- Status
- Terminated
- Initiated
- 2016-04-14
- Posted
- not on file
- Terminated
- 2019-03-27
- Reason
- MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component.
- 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
- 17
- Distribution
- Worldwide Distribution - US including OH, CA, NC and Internationally to China, Iraq, Japan, and Korea.
- Lot, serial or model codes
- US00586611, US00589878, US00594232, US00588464, US00591080, US00594779, US00588657, US00592182, US00594913, US00589391, US00593861, US00595298, US00589472, US00594092, US00595443, US00589851, US00594168
- 510(k) numbers
- ["K031187","K040404","K051134","K061707","K062233","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