Heart Sync C100-Physio Defibrillation Electrodes Recalled for Potential Energy Delivery Failure
Heart Sync, Inc. is recalling C100-Physio defibrillation electrodes due to a supplier issue that may prevent the device from delivering appropriate electrical shocks.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 where a defect could prevent the delivery of life-saving electrical shocks. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' as no specific patient injuries or deaths are cited in the source text.
Plain-English summary
Heart Sync, Inc. is recalling C100-Physio Radiotransparent Defibrillation Electrodes. These medical devices are used in connection with a defibrillator to deliver electrical current to a patient's heart during cardiac emergencies. The recall involves 17,180 units across specific part and lot numbers, distributed worldwide including the United States and South Korea.
The recall was initiated after Heart Sync became aware of a recall from a wire/connector sub-assembly supplier. Reports indicated equipment damage caused by misalignment from tooling installed in August 2012. This damage could render the device incapable of delivering the appropriate energy or shock to the patient.
Healthcare facilities and users should stop using the affected electrodes and contact Heart Sync, Inc. for further instructions on replacement or return. The affected part number is C100-Physio, with lot numbers Y100112-02, Y102212-03, Y121312-18, Y012413-02, Y022013-01, and Y032113-01.
The recalled product
- Product
- Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /ECG Monitoring electrodes Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during…
- Manufacturer
- Heart Sync, Inc
- Affected units
- 17,180
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 (6)
- Part number : C100-Physio and Lot numbers: Y100112-02
- Y102212-03
- Y121312-18
- Y012413-02
- Y022013-01
- Y032113-01
Distribution
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
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