GE OEC, Insta Trak 3500 Plus with the Cranial Application for Image Guided Surgery, GE Healthcare, Surgery, Salt Lake City, UT 84116
This recall has been terminated (originally issued January 23, 2008).
- Company
- Ge Oec Medical Systems, Inc
- Recall Initiated
- October 18, 2007
- Posted
- January 23, 2008
- Terminated
- August 10, 2012
- Recall Number
- Z-0183-2008
- Quantity
- 169 units
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Crack, Fracture or Detachment: The Transmitter Arm for the Mayfield-compatible Transmitter may become detached from the unit and enter into the surgical field.
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.
Lot / Code Info
Not applicable since this is an arm for all devices listed in product description.
Root Cause
Device Design
Action Taken
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.