ClearanceBrief
Recall Z-0709-06 ยท LLZ System, Image Processing, Radiological

GE OEC Medical Systems,Inc

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

DateApr 7, 2006 (initiated Feb 6, 2006)
StatusTerminated
ReasonSmall retaining pin may detach and fall into the surgical field during stereotactic surgery.
Root causeOther
ActionConsignees were notified by letter on 02/06/2006
Quantity186 units
DistributionAL, 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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K022069OEC FLUOROTRAK 9800 PLUS
Ge Oec Medical Systems, Sep 17, 2002
K983529INSTATRAK 3000
Visualization Technology, Inc., Dec 31, 1998
K994270INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000
Visualization Technology, Inc., Mar 9, 2000