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U.S. Department of Health and Human Services

Class 2 Device Recall InstaTrak 3500 Plus

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 Class 2 Recall
InstaTrak 3500 Plus
see related information
Date Posted January 23, 2008
Recall Status1 Open
Recall Number Z-0183-2008
Recall Event ID 45441
Premarket Notification
510(K) Number
K960330 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product GE OEC, Insta Trak 3500 Plus with the Cranial Application for Image Guided Surgery, GE Healthcare, Surgery, Salt Lake City, UT 84116
Code Information Not applicable since this is an arm for all devices listed in product description.
Recalling Firm/
Manufacturer
GE OEC Medical Systems, Inc
384 Wright Brothers Dr
Salt Lake City, Utah 84116-2862
Manufacturer Reason
for Recall
Crack, Fracture or Detachment: The Transmitter Arm for the Mayfield-compatible Transmitter may become detached from the unit and enter into the surgical field.
FDA Determined
Cause 2
DESIGN: Device Design
Action Consignees were sent an Urgent Recall Notice via mail dated 10/11/07, notifying the customer to examine the plastic end of the transmitter arm and to not use the transmitter arm, if any cracks or damage are observed. Also to stop using Steam Sterilization method and to utilize the other Sterilization methods indicated in the Operators Manual. The root cause is still under investigation GEHC Surgery will provide, at no charge, a solution to this issue when it becomes available.
Quantity in Commerce 169 units
Distribution Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, MA, MD, MI, MS, NC, NY, OK, OR, PA, SC, TX, UT, VA, WI, and WV, and countries of Canada, China, France, Hong Kong, Japan, Mexico, Spain, and Switzerland.
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 = LLZ and Original Applicant = VISUALIZATION TECHNOLOGY, INC.
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