Recall Z-0183-2008 ยท LLZ System, Image Processing, Radiological
GE OEC Medical Systems, Inc
GE OEC, Insta Trak 3500 Plus with the Cranial Application for Image Guided Surgery, GE Healthcare, Surgery, Salt Lake City, UT 84116
| Date | Jan 23, 2008 (initiated Oct 18, 2007) |
| Status | Terminated |
| Reason | Crack, Fracture or Detachment: The Transmitter Arm for the Mayfield-compatible Transmitter may become detached from the unit and enter into the surgical field. |
| Root cause | Device Design |
| Action | Consignees were sent an Urgent Recall Notice via mail dated 10/11/07, notifying the customer to examine the plastic end of the transmitter arm and to not use the transmitter arm, if any cracks or damage are observed. Also to stop using Steam Sterilization method and to utilize the other Sterilization methods indicated in the Operators Manual. The root cause is still under investigation GEHC Surgery will provide, at no charge, a solution to this issue when it becomes available. |
| Quantity | 169 units |
| Distribution | Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, MA, MD, MI, MS, NC, NY, OK, OR, PA, SC, TX, UT, VA, WI, and WV, and countries of Canada, China, France, Hong Kong, Japan, Mexico, Spain, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960330 | INSTATRAK Visualization Technology, Inc., Apr 8, 1996 |