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.
FDA Recall Z-0669-2010 · Posted 2010-02-02
Recalling FirmGe Healthcare
Recall StatusTerminated
Product CodeJAK
Date Initiated2009-10-01
Date Terminated2011-12-10
Product Quantity111 units total
Reason for Recall
Failure to properly document the CTDI in the Technical Reference or User Manual.
Firm 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.
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.