Heart Sync Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs
Heart Sync, Inc. is recalling Adult/Child Radiotransparent 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/Child Radiotransparent Electrodes, Part number C100AC-PHILIPS. These single-use electrodes are intended for defibrillation, cardioversion, pacing, and ECG monitoring. The recall involves 1,160 units sold in boxes of ten, distributed nationwide in the United States and in Thailand and South Korea.
The recall was initiated because the electrodes are incompatible with Philips FR3 and FRx AED units. The FRx unit requires pads to be pre-connected and will issue a continuous alarm if they are not, alerting the user to the issue. However, the FR3 unit does not require pre-connection, meaning a user may not discover the incompatibility until attempting to use the device. This failure to connect could prevent the delivery of defibrillation or other critical cardiac interventions.
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 recall number is Z-0584-2015.
The recalled product
- Product
- ADULT/CHILD Radiotransparent Electrode, Part number C100AC-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 C100AC-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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- SevereHeart Sync Electrodes Recalled for Incompatibility with Philips AEDs
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