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

Recall Z-1225-2014 — Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support (ALS), or another physici

U.S. FDA — Device Enforcement · United States · 2014-02-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1225-2014
Date of alert: 2014-02-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Philips Medical Systems North America Inc.
Product category: device
Product type: Devices

Reported risk: Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed Circuit Board (PCB), which contains the circuitry that supplies energy to the device, could become separated from the electrical contact points that hold the board in place. In the event the PCB becomes separated from the electrical contact points, the AED may not be ready to deliver a shock in the event of an emergency.

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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