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.
Enforcement
- Recall Number
- Z-2035-2018
- Event ID
- 79982
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips Electronics North America Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 6, 2018
- Initiation Date
- May 3, 2018
- Classification Date
- May 30, 2018
- Termination Date
- October 17, 2019
- Address
- 3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States
Description
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.
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.
US00588464, US00588657, US00589878, US00591080, US00593861
Worldwide Distribution to accounts in OH and NC. Foreign distribution to Lebanon.
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