Class 2 Device Recall LightSpeed VCT 7.2 Vision

• Date Initiated by Firm: October 01, 2009
• Date Posted: February 02, 2010
• Recall Status: Terminated on December 10, 2011
• Recall Number: Z-0669-2010
• Recall Event ID: 54178
• Product Classification: Computed Tomography X-Ray System. - Product Code JAK
• Product: LightSpeed VCT 7.2 Vision model numbers: 5212920-300 console used with 5129909, 5129909-5, and 5129909-11 gantry.; ; For head, whole body, cardiac and vascular X-ray Computed Tomography applications.
• Code Information: Serial numbers associated with the mentioned Gantry model numbers manufactured from May 2009 to November 2009.
• Recalling Firm/ Manufacturer: Ge Healthcare; 9900 W Innovation Dr; Wauwatosa WI 53226-4856
• Manufacturer Reason for Recall: Failure to properly document the CTDI in the Technical Reference or User Manual.
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: GE is sending an Important Electronic Product Radiation Warning letter to customers. The letter will describe the defect, identify the affected product details, provide instructions, state the product correction, and the necessary contact information.
• Quantity in Commerce: 111 units total
• Distribution: Nationwide Distribution -- Including states of CT, SD, VA, WA, MA, PA, GA, IL, CA, MD, NY, NC, SC, AZ, TX, MT, FL, OH, OK, MI, CO, ME, WV, TN, KS, and WI.
• 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.