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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
GE LightSpeed RT16 CT Scanner System 		see related information
Date Posted February 15, 2007
Recall Number Z-0506-2007
Product The LightSpeed RT16 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. The system is capable of generating images for the guidance of minimally invasive procedures such as biopsy and ablation of tumors and pathology. The system allows imaging of obese patients, up to and including the obese population (BMI > 40). When used in the LightSpeed RT 16 configuration, the system acquires CT anatomical images that are clinically useful in the simulation and planning of radiation therapy for the treatment of cancer.
Code Information All serial numbers
Recalling Firm/
Manufacturer		 GE Healthcare
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Reason for
Recall		 When the manual cradle release feature on the table is used to move a patient out of the gantry, a discrepancy of up to 6mm between the numerical display on the gantry and the actual position of the table could be introduced.
Action A Product Safety Advisory Notice, dated December 8, 2006, was issued to all customers informing them of the safety issue and production correction. Customers are advised to operate the CT cradle as intended with the system''s electronic controls. If a critical need arises to release the cradle during a radiation therapy simulation scan, they are advised to independently verify patient position prior to marking the patient for therapy to avoid the potential inaccuracy. A software update will be installed to correct this problem by a GE representative.
Quantity in Commerce 22 units
Distribution Worldwide, including USA, Puerto Rico, Albania, Argentina, Austria, Australia, Belarus, Belgium, Bulgaria, Brazil, Canada, Chile, China, Columbia, Denmark, Finland, France, Germany, Great Britain, Greece, Guam, Hong Kong, Honduras, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia , Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Reunion Island, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain , Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Venezuela, Vietnam, and Yugoslavia.
 
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