Recall Z-2035-2018 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Electronics North America Corporation
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 suppor
| Date | May 3, 2018 |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 5 |
| Distribution | Worldwide Distribution to accounts in OH and NC. Foreign distribution to Lebanon. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063375 | HEARTSTART MRX, MODELS M3535A OR M3536A Philips Medical Systems, Jan 11, 2007 |