CLASS I Device recall · Reported 31 Dec 2014 · FDA Enforcement Report
Adult/Child Radiotranslucent Electrode recalled by Heart Sync
Heart Sync is recalling Adult/Child Radiotranslucent Electrode, distributed nationwide in the US. The recall was initiated on 11 Nov 2014 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0587-2015
- FDA event ID
- 69875
- Recalling firm
- Heart Sync, Ann Arbor, MI
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 11 Nov 2014
- FDA classified
- 23 Dec 2014
- Reported
- 31 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 11 Nov 2014 | Recall initiated by company | |
| 23 Dec 2014 | Classified by FDA | +42 days |
| 31 Dec 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-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.
Where it was distributed
Worldwide Distribution - USA (Nationwide) in the states of NM, VT, MN, IL, MO, OH, MI, OR, ND, KY, PA, TX, WA, FL, NE, AR, VA, DE, GA, NY, CA, TN, AZ, RI, MA, and PR; and countries of: Thailand and South Korea.
Nationwide ArkansasArizonaCaliforniaDelawareFloridaGeorgiaIllinoisKentuckyMassachusettsMichiganMinnesotaMissouriNorth DakotaNebraskaNew MexicoNew YorkOhioOregonPennsylvaniaPuerto Rico
Questions about this recall
Why was it recalled?
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
Which lots are affected?
All Lots. Catalog / Part Number T100AC-PHILIPS
Where was it sold?
Worldwide Distribution - USA (Nationwide) in the states of NM, VT, MN, IL, MO, OH, MI, OR, ND, KY, PA, TX, WA, FL, NE, AR, VA, DE, GA, NY, CA, TN, AZ, RI, MA, and PR; and countries of: Thailand and South Korea.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 69875This product is part of a recall event; the main page for the event is Adult Radiotranslucent Electrode recalled by Heart Sync.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Adult Radiotranslucent Electrode recalled by Heart Sync | Heart Sync | Device Malfunction | Nationwide | |
| CLASS I | Adult Radiotransparent Electrode recalled by Heart Sync | Heart Sync | Device Malfunction | Nationwide | |
| CLASS I | Adult Radiotranslucent Electrode recalled by Heart Sync | Heart Sync | Device Malfunction | Nationwide | |
| CLASS I | Adult/Child Radiotransparent Electrode recalled by Heart Sync | Heart Sync | Device Malfunction | Nationwide |
More recalls from Heart Sync
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Adult/Child Radiotransparent Electrode recalled by Heart Sync | Heart Sync | Device Malfunction | Nationwide |
| Device | CLASS I | Adult Radiotranslucent Electrode recalled by Heart Sync | Heart Sync | Device Malfunction | Nationwide |
| Device | CLASS I | Adult Radiotransparent Electrode recalled by Heart Sync | Heart Sync | Device Malfunction | Nationwide |
| Device | CLASS I | Adult Radiotranslucent Electrode recalled by Heart Sync | Heart Sync | Device Malfunction | Nationwide |
| Device | CLASS II | Vermed, Inc Radiotransparent Defibrillation Electrodes recalled | Heart Sync | Other | 13 states |
Other Patient Monitors recalls
All 1,013| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |