Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0709-06

GE Healthcare Navigation Pin Transmitter (GE P/N 1004070) -Medical Systems InstaTrak Pin Transmitter

GE Healthcare / initiated 2006-02-06 / Terminated

GE OEC Medical Systems,Inc began a recall of GE Healthcare Navigation Pin Transmitter (GE P/N 1004070) -Medical Systems InstaTrak Pin Transmitter on . The reason FDA records is "Small retaining pin may detach and fall into the surgical field during stereotactic surgery". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0709-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
GE Healthcare
Product
GE Healthcare Navigation Pin Transmitter (GE P/N 1004070) -Medical Systems InstaTrak Pin Transmitter
Product code
LLZ System, Image Processing, Radiological
Reason for recall
Small retaining pin may detach and fall into the surgical field during stereotactic surgery.
FDA root cause
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.
Product codes and lots
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.