GE Healthcare Navigation Pin Transmitter (GE P/N 1004070) -Medical Systems InstaTrak Pin Transmitter
This recall has been terminated (originally issued April 7, 2006).
- Company
- Ge Oec Medical Systems, Inc
- Recall Initiated
- February 6, 2006
- Posted
- April 7, 2006
- Terminated
- August 18, 2011
- Recall Number
- Z-0709-06
- Quantity
- 186 units
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Small retaining pin may detach and fall into the surgical field during stereotactic surgery.
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.
Lot / Code Info
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.
Root Cause
Other
Action Taken
Consignees were notified by letter on 02/06/2006