| Class 2 Device Recall GE LightSpeed RT16 CT Scanner System | |
Date Initiated by Firm | December 08, 2006 |
Date Posted | February 15, 2007 |
Recall Status1 |
Terminated 3 on November 30, 2007 |
Recall Number | Z-0506-2007 |
Recall Event ID |
37028 |
510(K)Number | K060052 |
Product Classification |
X-ray Computed Tomography - Product Code JAK
|
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 WI 53188-1615
|
For Additional Information Contact | 262-544-3894 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 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. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = JAK
|
|
|
|