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Class 2 Device Recall InstaTrak 3500 Plus |
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Date Initiated by Firm |
October 18, 2007 |
Date Posted |
January 23, 2008 |
Recall Status1 |
Terminated 3 on August 10, 2012 |
Recall Number |
Z-0183-2008 |
Recall Event ID |
45441 |
510(K)Number |
K960330
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Product Classification |
Image Processing Radiological System, - Product Code LLZ
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Product |
GE OEC, Insta Trak 3500 Plus with the Cranial Application for Image Guided Surgery, GE Healthcare, Surgery, Salt Lake City, UT 84116
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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 UT 84116-2862
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For Additional Information Contact |
801-517-6440
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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.
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FDA Determined Cause 2 |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = VISUALIZATION TECHNOLOGY, INC.
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