GE LightSpeed Xtra / GE LightSpeed RT Pro 16, Model 2374681-6, CT Scanner systems.
This recall has been terminated (originally issued May 15, 2007).
- Company
- Ge Healthcare
- Recall Initiated
- December 21, 2006
- Posted
- May 15, 2007
- Terminated
- July 3, 2012
- Recall Number
- Z-0805-2007
- Quantity
- 21
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
Reason for Recall
Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis.
Distribution
Worldwide Distribution: USA in the following states and locations: AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, Guam and Puerto Rico. Foreign countries include ; Albania, Algeria, Argentina, Austria, Australia, Belgium, Bulgaria, Brazil, Belarus, Canada, Chile, China, Columbia, Czechoslovakia, Denmark, Finland, France, Germany, Great Britain, Greece, Honduras, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Reunion Island, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Venezuela, and Vietnam
Lot / Code Info
All serial numbers
Root Cause
Other
Action Taken
A Field Modification Instruction was issued to the field to inspect all systems and replace the tube window screws and the window filter, as well as clean any traces of oil in the tube window area. A 12/21/2006, Urgent Product Correction Notice/Customer letter has also been distributed informing the customers of the safety issue and the product correction.