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.
This recall has been terminated (originally issued February 2, 2010).
- Company
- Ge Healthcare
- Recall Initiated
- October 1, 2009
- Posted
- February 2, 2010
- Terminated
- December 10, 2011
- Recall Number
- Z-0669-2010
- Quantity
- 111 units total
- Firm Location
- Wauwatosa, WI
- Official Source
- View on FDA website ↗
Reason for Recall
Failure to properly document the CTDI in the Technical Reference or User Manual.
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.
Lot / Code Info
Serial numbers associated with the mentioned Gantry model numbers manufactured from May 2009 to November 2009.
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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.
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