FDA Device recall Z-0458-2015
ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE C…
- FDA Device
- Class I
- terminated
- Published 2014-12-10
On 2014-12-10 the FDA classified a Class I recall of ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE C… by Conmed, citing 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 resul….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0458-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-11-06 |
| Published | 2014-12-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Conmed |
| Distribution | US |
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.
Identifiers
| code_info | All Lot Codes |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0458-2015%22
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