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U.S. Department of Health and Human Services

Class 2 Device Recall GE LightSpeed VCT System

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 Class 2 Device Recall GE LightSpeed VCT Systemsee related information
Date Initiated by FirmDecember 08, 2006
Date PostedFebruary 15, 2007
Recall Status1 Terminated 3 on November 30, 2007
Recall NumberZ-0507-2007
Recall Event ID 37028
510(K)NumberK040372 
Product Classification X-ray Computed Tomography - Product Code JAK
ProductThe LightSpeed VCT System is intended for head and whole body X-ray Computed Tomography applications.
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
ActionA 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 Commerce1,256 units
DistributionWorldwide, 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 CycleTPLC 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) Database510(K)s with Product Code = JAK
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