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.
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 medical device used for life-saving defibrillation where a functional defect could prevent treatment, fitting the 'High' criterion for risk-of-harm products where injury has not yet been reported.
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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