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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a functional defect could prevent life-saving defibrillation, representing a risk of harm where injury has not yet been reported.
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
Same manufacturer · Heart Sync, Inc.
See all →- HighHeart Sync Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs
FDA (Devices) · 2014-12-31
- SevereHeart Sync Electrodes Recalled for Incompatibility with Philips AEDs
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- HighHeart Sync Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs
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- HighHeart Sync Electrodes Recalled for Incompatibility with Philips AEDs
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- HighHeart Sync Recalls Radiotransparent Defibrillation Electrodes Due to Equipment Damage
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