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Class 2 Device Recall Spine Clamp |
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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
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Product Classification |
System, Image Processing, Radiological - Product Code LLZ
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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
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For Additional Information Contact |
801-536-4668
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Manufacturer Reason for Recall |
Threads on this accessory spine clamp may become tight, which may make it difficult to install or remove.
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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
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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 = GE MEDICAL SYSTEMS NAVIGATION AND VISUALIZATION IN
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