FDA Device recall Z-2035-2018
HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) P…
- FDA Device
- Class II
- terminated
- Published 2018-06-06
On 2018-06-06 the FDA classified a Class II recall of HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) P… by Philips Electronics North America, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2035-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-03 |
| Published | 2018-06-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | NC, OH |
Product
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
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.
Identifiers
| code_info | US00588464, US00588657, US00589878, US00591080, US00593861 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Philips Electronics North America
- Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483…
FDA Device · Class II · 2018-12-26 · Philips Electronics North America - IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals…
FDA Device · Class II · 2018-12-19 · Philips Electronics North America - Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventric…
FDA Device · Class II · 2018-10-24 · Philips Electronics North America - INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications includi…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - Allura Xper FD2O Biplane, System Code 722008 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America
All Philips Electronics North America recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2035-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.