Z-2035-2018 Class II Terminated
FDA device recall Z-2035-2018 was initiated by Philips Electronics North America Corporation on May 3, 2018 and is designated Class II. 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… The recall status is terminated (terminated Oct 17, 2019). Affected quantity: 5.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 6, 2018
- Initiation Date
- May 3, 2018
- Termination Date
- Oct 17, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
Product 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.
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 Pattern
Worldwide Distribution to accounts in OH and NC. Foreign distribution to Lebanon.
Code Information
US00588464, US00588657, US00589878, US00591080, US00593861
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2035-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026