Heart Sync recalls
Heart Sync appears in 7 official U.S. recall notices indexed by RecallRadar, most recently on 2014-12-31.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 7 |
|---|---|
| Published | 2013-06-05 to 2014-12-31 |
| By agency | FDA Device (7) |
| By classification | Class I (5), Class II (2) |
| By status | terminated (7) |
| Distribution named in notices | AL, GA, MA, MI, MN, NC, ND, OH, PA, SD, TX, US, VA, VT |
Recalls
- ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical H…
FDA Device · Class I · 2014-12-31 · Heart Sync
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 t… - 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
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 t… - 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
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 t… - 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
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 t… - 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
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 t… - Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring…
FDA Device · Class II · 2013-06-05 · Heart Sync
Reason: On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment from tooling installe… - Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /E…
FDA Device · Class II · 2013-06-05 · Heart Sync
Reason: On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment from tooling installe…