Heart Sync Multi-function Defibrillation Electrodes Recalled for Incompatibility
Heart Sync, Inc. is recalling multi-function defibrillation electrodes that do not connect with Philips FR3 or FRx AED units, potentially preventing proper use.
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 its ADULT Radiotranslucent Electrodes (Part number T100-PHILIPS) because they will not connect with Philips FR3 or FRx AED units. The product is intended for use during defibrillation, cardioversion, pacing, and ECG monitoring.
The incompatibility poses a risk because the Philips FRx AED unit requires pads to be pre-connected and will issue a continuous alarm chirp to alert the user if the proper pads are not connected. However, the Philips FR3 unit does not require pre-connection, meaning a user may not discover the incompatibility issue until the device is in use. The recall involves 46,929 units distributed nationwide in the United States and in Thailand and South Korea.
Consumers and healthcare facilities should stop using these electrodes with Philips FR3 or FRx AED units. Users should contact Heart Sync, Inc. for further instructions or a replacement.
The recalled product
- Product
- ADULT Radiotranslucent Electrode, Part number T100-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 T100-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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See all →- SevereHeart Sync Electrodes Recalled for Incompatibility with Philips AEDs
FDA (Devices) · 2014-12-31
- SevereHeart Sync Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs
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