ADULT Radiotransparent Electrode — Class I medical device recall Z-0583-2015
Terminated recall by Heart Sync, Inc., reported 2014-12-31, distributed nationwide. Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FR
| Recall number | Z-0583-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heart Sync, Inc., Ann Arbor, MI, United States |
| Recall initiated | 2014-11-11 |
| Classified | 2014-12-23 |
| Reported by FDA | 2014-12-31 |
| Terminated | 2015-11-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | KR, TH |
| Model numbers | C100-PHILIPS |
Product
ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.
Reason for recall
Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user may not discover the incompatibility issue until the
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-0583-2015. 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.