FDA Device recall Z-0585-2015
ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical H…
- FDA Device
- Class I
- terminated
- Published 2014-12-31
On 2014-12-31 the FDA classified a Class I recall of ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical H… by Heart Sync, citing 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 co….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0585-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-11-11 |
| Published | 2014-12-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Heart Sync |
| Distribution | US |
Product
ADULT Radiotranslucent Electrode, Part number T100LO-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
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
Identifiers
| code_info | All Lots. Catalog / Part Number T100LO-PHILIPS |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Heart Sync
- ADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Med…
FDA Device · Class I · 2014-12-31 · Heart Sync - ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical Hea…
FDA Device · Class I · 2014-12-31 · Heart Sync - ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical Hea…
FDA Device · Class I · 2014-12-31 · Heart Sync - ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Med…
FDA Device · Class I · 2014-12-31 · Heart Sync - Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring…
FDA Device · Class II · 2013-06-05 · Heart Sync
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0585-2015%22
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