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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 Clampsee related information
Date Initiated by FirmSeptember 15, 2004
Date PostedNovember 03, 2004
Recall Status1 Terminated 3 on July 07, 2011
Recall NumberZ-0155-05
Recall Event ID 30035
510(K)NumberK040050 
Product Classification System, Image Processing, Radiological - Product Code LLZ
ProductSpine 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.
FEI Number 1720753
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
ActionConsignees were notified by letter on 9/15/2004.
Quantity in Commerce114 units
DistributionAL, 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 CycleTPLC 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) Database510(K)s with Product Code = LLZ
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