—#49787

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.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K060052
Affected lot / code info: All serial numbers

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: GE Healthcare
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2006-12-08
Posted by FDA: 2007-02-15
Terminated: 2007-11-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49787. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.