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U.S. Department of Health and Human Services

Class 2 Device Recall Heart Sync C100Physio Radiotransparent Defibrillation Electrodes

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 Class 2 Recall
Heart Sync C100Physio Radiotransparent Defibrillation Electrodes
see related information
Date Posted May 30, 2013
Recall Status1 Open
Recall Number Z-1434-2013
Recall Event ID 65085
Premarket Notification
510(K) Number
K080421 
Product Classification Electrode, Pacemaker, Temporary - Product Code LDF
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 cardiac emergencies.
Code Information Part number : C100-Physio and Lot numbers: Y100112-02, Y102212-03, Y121312-18, Y012413-02, Y022013-01, Y032113-01
Recalling Firm/
Manufacturer
Heart Sync, Inc
5643 Plymouth Rd
Ann Arbor, Michigan 48105-9586
For Additional Information Contact Cathy Hagerman
734-213-5530
Manufacturer Reason
for Recall
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 Determined
Cause 2
DESIGN: Process Design
Action HeartSync sent an URGENT MEDICAL DEVICE RECALL notification letter dated April 26, 2013, to all consignees of Heart Sync for C100-Physio Radiotransparent Defrillation Electrodes. On April 29, 2013, an URGENT MEDICAL DEVICE RECALL notification was sent to Vermed Inc for the D304 Defrillation Electrodes . The letters identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the affected product to the firm for full credit. Customers were asked to complete the form and send back via fax to 734-213-5640 or call 734-213-5530. For questions regarding this recall call 734-213-5530. .
Quantity in Commerce 17180 units for all part numbers
Distribution Worldwide Distribution - USA including AL, GA, MI, MN, NC, ND, OH, PA, SD, VA, VT, OH, TX, MA, and Internationally to Korea.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LDF and Original Applicant = HEART SYNC LLC
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