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

Recall Z-1090-2014 — HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A, M3536A, M3536J, M3536MC 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 t

U.S. FDA — Device Enforcement · United States · 2014-02-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1090-2014
Date of alert: 2014-02-18
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Philips Medical Systems, Inc.
Product category: device
Product type: Devices

Reported risk: A component of the MRx Processor Board may be susceptible to damage from electrostatic discharge (ESD), which can disrupt ECG and SpO2 functionality leading to an inability to perform.

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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