Recall Z-0458-2015— ConMed Corporation
Class I · Terminated
Class I FDA medical device recall by ConMed Corporation, initiated 2014-11-06, terminated 2017-10-30. It names one FDA 510(k) clearance: K020203. Product: ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR. 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..
- Recalling firm
- ConMed Corporation
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-11-06
- Terminated
- 2017-10-30
- Firm location
- Utica, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC, 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.