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

Recall Z-0455-2015 — ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR

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-0455-2015
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.

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