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U.S. Department of Health and Human Services

Class 2 Device Recall Spine Clamp

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  Class 2 Device Recall Spine Clamp see related information
Date Initiated by Firm September 15, 2004
Date Posted November 03, 2004
Recall Status1 Terminated 3 on July 07, 2011
Recall Number Z-0155-05
Recall Event ID 30035
510(K)Number K040050  
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Spine Clamp, an accessory to the InstaTrak 3500 Plus system. Clamp is attached to the spine to provide a mounting point for a transmitter.
Code Information Part Number: GE 1005556.
Recalling Firm/
Manufacturer		 GE OEC Medical Systems,Inc
384 Wright Brothers Dr
Salt Lake City UT 84116-2862
For Additional Information Contact
801-536-4668
Manufacturer Reason
for Recall		 Threads on this accessory spine clamp may become tight, which may make it difficult to install or remove.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter on 9/15/2004.
Quantity in Commerce 114 units
Distribution AL, CO, CA, FL, GA, LA, IL, IN, MA, MD, MI, MS, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI, WV, including one VA facility in TN. No military or foreign distribution.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = GE MEDICAL SYSTEMS NAVIGATION AND VISUALIZATION IN
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