Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2035-2018 — 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 qualifie

U.S. FDA — Device Enforcement · United States · 2018-05-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2035-2018
Date of alert: 2018-05-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Philips Electronics North America Corporation
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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