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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

ConMed Corporation: 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.

Agency Publication Date: December 4, 2014
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Affected Products

Product: ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.

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Product: ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR

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Product: ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR

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Product: ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR

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Product: ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR

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Product: PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2603H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR

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Product: MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR--Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.

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Product: 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.

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Product: CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, 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.

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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 69752
Status: Resolved
Manufacturer: ConMed Corporation
Manufactured In: United States
Units Affected: 9 products (174,610 (168,090 US and 6,520 OUS) in total.)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.