Heart Sync Electrodes Recalled for Incompatibility with Philips AEDs
Heart Sync, Inc. is recalling multi-function defibrillation electrodes that do not connect with Philips FR3 or FRx AED units, potentially preventing proper device operation.
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/CHILD Radiotranslucent Electrodes, Part number T100AC-PHILIPS. The recall involves 209 boxes containing a total of 2,090 single-use electrodes. These products were distributed nationwide in the United States and internationally in Thailand and South Korea.
The recall is being issued because the electrodes will not connect with Philips FR3 or FRx AED units. The 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 FR3 unit does not require pre-connection, meaning a user may not discover the incompatibility until attempting to use the device.
Users of these electrodes should stop using them with Philips FR3 or FRx AED units. The source text does not specify a contact method for returns or refunds, but users should verify compatibility with their specific AED model before use.
The recalled product
- Product
- 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…
- 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 T100AC-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
Same manufacturer · Heart Sync, Inc.
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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- SevereHeart Sync Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs
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- SevereHeart Sync Multi-function Defibrillation Electrodes Recalled for Incompatibility
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