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Heart Sync, Inc recalls Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/p
Recalled June 5, 2013 · FDA recall Z-1435-2013 · Heart Sync
Hazard
On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment from tooling installed in August 2012. The result of this damage could render the device incapable of delivering the appropriate energy or shock to the patient. · FDA Class II
Units
17180 units for all part numbers
Sold at
Worldwide Distribution - USA including AL, GA, MI, MN, NC, ND, OH, PA, SD, VA, VT, OH, TX, MA, and Internationally to Korea.
Description
On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment from tooling installed in August 2012. The result of this damage could render the device incapable of delivering the appropriate energy or shock to the patient.
Product
Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes. Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies.
Manufacturer(s)
Heart Sync, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →