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U.S. Department of Health and Human Services

Class 3 Device Recall Pin Transmitter

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  Class 3 Device Recall Pin Transmitter see related information
Date Initiated by Firm February 06, 2006
Date Posted April 07, 2006
Recall Status1 Terminated 3 on August 18, 2011
Recall Number Z-0709-06
Recall Event ID 34730
510(K)Number K983529  K994270  K022069  
Product Classification Navigation Pin Transmitter - Product Code LLZ
Product GE Healthcare Navigation Pin Transmitter (GE P/N 1004070) -Medical Systems InstaTrak Pin Transmitter
Code Information Catalog Number 1004070. Serial numbers: 82-2771-N, 822920-N, 82-2921-N, 82-3012-N, 82-3188-N, 82-3189-N, 82-3289-N, 89-2453-N, 89-2509-N, 89-2524-N, 89-2529-N, 89-2742-N, 89-2743-N, 89-3121-N, 89-3122-N, 89-3123-N, 8S-2094-N, 8S-2150-N, 8S2151-N, 8S-2177-N, 8S-2178-N, 8S-2179-N, 8S-2223-N, 8S-2224-N, 8S-2225-N, 8S-2226-N, 8S-2244-N, 8S-2261-N, 8S-2262-N, 8S-2292-N, 8S-2336-N, 8S-2337-N, 8S-2338-N, 8S-2339-N, 8S-2340-N, 8S-2341-N, 8S-2376-N, 8S-2380-N, 8S-2386-N, 8S-2390-N, 8S-2394-N, 8S-2443-N, 8S-2444-N, 8S-2445-N, 8S-2515-N, 8S-2516-N, 8S-2524-N, 8S-2549-N, 8S-2589-N, 8S-2590-N, 8S-2591-N, IT25147P, IT25169P, IT35153P, IT35184P, IT35191P, IT35197P, IT35198P, IT35207P, IT35208P, IT35209P, IT35211P, IT35214P, IT35216P, IT35221P, IT35223P, IT35225P, IT35226P, IT35228P, IT35232P, IT35234P, IT35240P, IT35242P, IT35244P, IT35245P, IT35250P, IT35255P, IT35260P, IT35262P, IT35263P, IT35267P, IT35269P, IT35272P, IT35275P, IT35280P, IT35285P, IT35287P, IT35291P, IT35292P, IT35293P, IT35294P, IT35295P, IT35296P, IT35299P, IT35301P, IT35302P, IT35304P, IT35305P, IT35312P, IT35315P, IT35316P, IT35317P, IT35323P, IT35324P, IT35327P, IT35328P, IT35330P, IT35336P, IT35339P, IT35342P, IT35344P, IT35348P, IT35361P, IT 35370P, IT35375P, IT35379P, IT35381P, IT35383P.  
Recalling Firm/
Manufacturer		 GE OEC Medical Systems,Inc
384 Wright Brothers Dr
Salt Lake City UT 84116-2862
Manufacturer Reason
for Recall		 Small retaining pin may detach and fall into the surgical field during stereotactic surgery.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter on 02/06/2006
Quantity in Commerce 186 units
Distribution AL, AZ, CA, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NJ, NV, NY, OR, PA, SC, TN, TX, UT, VA, WI, WV and one military facility in DC. Foreign distribution to Canada, Denmark, France Germany, Hong Kong, Italy, Japan, Switzerland, UK.
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 OEC MEDICAL SYSTEMS
510(K)s with Product Code = LLZ and Original Applicant = VISUALIZATION TECHNOLOGY, INC.
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