Recall Z-0506-2007 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare
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 conf
| Date | Feb 15, 2007 (initiated Dec 8, 2006) |
| Status | Terminated |
| Reason | 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 | Other |
| 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 | 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, Leba |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060052 | GE LIGHTSPEED XTRA CT SCANNER SYSTEM Ge Medical Systems, LLC, Apr 19, 2006 |