PlainRecordsFDA · Medical device recall
The LightSpeed RT16 CT Scanner System is indicated for head and whole… and 1 more product
- Date posted by the FDA
- Feb. 15, 2007
- Status
- Terminated
- Filed by
- GE Healthcare
- 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.
- 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.
2 products in this recall
The LightSpeed RT16 CT Scanner System is indicated for head and whole body X-ray Computed Tomography…
- 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.
- Quantity
- 22 units
- Codes and lots
- All serial numbers
- Recall started
- Dec. 8, 2006
- Device type
- System, X-Ray, Tomography, Computed
- Root cause (FDA)
- Other
- What the company told customers
- 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.
- Recall number
- Z-0506-2007
The LightSpeed VCT System is intended for head and whole body X-ray Computed Tomography applications
- Product
- The LightSpeed VCT System is intended for head and whole body X-ray Computed Tomography applications.
- Quantity
- 1,256 units
- Codes and lots
- All serial numbers
- Recall started
- Dec. 8, 2006
- Device type
- System, X-Ray, Tomography, Computed
- Root cause (FDA)
- Other
- What the company told customers
- 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.
- Recall number
- Z-0507-2007
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0506-2007, Z-0507-2007. The agency record governs; check it and the company before acting.