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

Recall Z-2488-2019 — HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automatic mode (AED). In manual mode, the HeartStart MRx is a full featured manual defi

U.S. FDA — Device Enforcement · United States · 2019-07-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2488-2019
Date of alert: 2019-07-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Philips North America, LLC
Product category: device
Product type: Devices

Reported risk: Non-conforming devices are identified, which may not have been included in prior field actions and may not have had a number of corrections applicable to these devices.

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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