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.
This recall has been terminated (originally issued May 3, 2018).
- Recall Initiated
- May 3, 2018
- Terminated
- October 17, 2019
- Recall Number
- Z-2035-2018
- Quantity
- 5
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution to accounts in OH and NC. Foreign distribution to Lebanon.
Lot / Code Info
US00588464, US00588657, US00589878, US00591080, US00593861
Root Cause
Employee error
Action Taken
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.