Heart Sync Electrodes Recalled for Incompatibility with Philips AEDs
Heart Sync, Inc. is recalling Adult Radiotransparent Electrodes that fail to 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 recall involves a medical device defect that prevents defibrillation, a life-saving procedure. This constitutes a significant risk of serious injury or death due to device failure, aligning with the 'Severe' criteria for significant injury reports or high-risk device defects.
Plain-English summary
Heart Sync, Inc. is recalling Adult Radiotransparent Electrodes (Part number C100-PHILIPS) intended for use with Philips HeartStart AEDs. The recall is due to a defect where the electrodes will not connect with Philips FR3 or FRx AED units. This incompatibility may prevent the AED from functioning properly during defibrillation, cardioversion, pacing, or ECG monitoring.
The affected product is sold in boxes of ten electrodes, with a total of 46,638 units distributed. The recall covers all lots of the C100-PHILIPS part number. Distribution was nationwide in the United States, including specific states such as NM, VT, MN, IL, MO, OH, MI, OR, ND, KY, PA, TX, WA, FL, NE, AR, VA, DE, GA, NY, CA, TN, AZ, RI, and MA, as well as Puerto Rico. The product was also distributed in Thailand and South Korea.
Users of Philips FRx AED units may notice a continuous alarm chirp indicating that proper pads are not connected. Users of Philips FR3 units may not discover the incompatibility until attempting to use the device. Consumers and healthcare facilities should stop using these electrodes and contact Heart Sync, Inc. for instructions on return or replacement.
The recalled product
- Product
- ADULT Radiotransparent Electrode, Part number C100-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 C100-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 Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs
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