ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
Reported: December 10, 2014 Initiated: November 6, 2014 #Z-0457-2015
Product Description
ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
Reason for Recall
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.
Details
- Recalling Firm
- ConMed Corporation
- Units Affected
- 174,610 (168,090 US and 6,520 OUS) in total.
- Distribution
- 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.
- Location
- Utica, NY
Frequently Asked Questions
What product was recalled? ▼
ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR. Recalled by ConMed Corporation. Units affected: 174,610 (168,090 US and 6,520 OUS) in total..
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 10, 2014. Severity: Critical. Recall number: Z-0457-2015.
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