Heart Sync Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs
Heart Sync, Inc. is recalling Adult Radiotranslucent Electrodes because they do not connect with Philips FR3 or FRx AED units, potentially preventing defibrillation.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"
Plain-English summary
Heart Sync, Inc. is recalling Adult Radiotranslucent Electrodes (Part number T100LO-PHILIPS) because they are incompatible with Philips FR3 and FRx AED units. The recall involves 17,913 units sold in boxes of ten. These electrodes are intended for use during defibrillation, cardioversion, pacing, and ECG monitoring.
The incompatibility means the electrodes will not connect properly to the specified Philips AED models. For the FRx AED, the unit requires pads to be pre-connected and will issue a continuous alarm chirp to alert the user that the proper pads are not connected. For the FR3 AED, which does not require pre-connection, the user may not discover the incompatibility until attempting to use the device.
The affected products were distributed nationwide in the United States and in Thailand and South Korea. Users should stop using these electrodes with Philips FR3 or FRx AED units and contact Heart Sync, Inc. for instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- Heart Sync, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots. Catalog / Part Number T100LO-PHILIPS
Distribution
Part of a larger recall action
This product is one of 5 recalled by Heart Sync, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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