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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Event Detail

Event ID 65085
Product Type Devices
Status Ongoing
Recalling Firm Heart Sync, Inc
City Ann Arbor
State MI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-26
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Worldwide Distribution - USA including AL, GA, MI, MN, NC, ND, OH, PA, SD, VA, VT, OH, TX, MA, and Internationally to Korea.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Part Number: D304 and lot numbers:Y100112-02, Y102212-03, Y121312-18, Y012413-02, Y022013-01, Y032113-01 Class II 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. 17180 units for all part numbers Z-1435-2013
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 cardiac emergencies. Part number : C100-Physio and Lot numbers: Y100112-02, Y102212-03, Y121312-18, Y012413-02, Y022013-01, Y032113-01 Class II 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. 17180 units for all part numbers Z-1434-2013
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