—#145058

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.

FDA product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K031187, K040404, K051134, K061707, K062233, K063375
Affected lot / code info: US00586611, US00589878, US00594232, US00588464, US00591080, US00594779, US00588657, US00592182, US00594913, US00589391, US00593861, US00595298, US00589472, US00594092, US00595443, US00589851, US00594168

Why it was recalled

MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Philips Electronics North America Corporation
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Worldwide Distribution - US including OH, CA, NC and Internationally to China, Iraq, Japan, and Korea.

Timeline

Recall initiated: 2016-04-14
Terminated: 2019-03-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #145058. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.