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Recall Observatory FDA recall evidence

Device product

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

Z-0457-2015

November 06, 2014

Class I

Product summary

Firm
ConMed Corporation
Event
Event 69752
Status
Terminated
Classification
Class I
Quantity
174,610 (168,090 US and 6,520 OUS) in total.
Official record key
device-enforcement:Z-0457-2015

Official wording

Reason: 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.

Code information: All Lot Codes

Distribution pattern: Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.