ADULT Radiotransparent Electrode — Class I medical device recall Z-0458-2015
Terminated recall by ConMed Corporation, reported 2014-12-10, distributed nationwide. Philips Healthcare made changes to the design of the connection between multifunction electrodes and their Hea
| Recall number | Z-0458-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConMed Corporation, Utica, NY, United States |
| Recall initiated | 2014-11-06 |
| Classified | 2014-12-04 |
| Reported by FDA | 2014-12-10 |
| Terminated | 2017-10-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, ES, GB, IL, IT, KR, NO, PT, SA |
| Model numbers | 2516H-PC |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0458-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.