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

Recall Z-0461-2015 — CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.

U.S. FDA — Device Enforcement · United States · 2014-11-06 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0461-2015
Date of alert: 2014-11-06
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: ConMed Corporation
Product category: device
Product type: Devices

Reported risk: Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.

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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