Recall Z-0669-2010 ยท JAK System, X-Ray, Tomography, Computed
Ge Healthcare
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.
| Date | Feb 2, 2010 (initiated Oct 1, 2009) |
| Status | Terminated |
| Reason | Failure to properly document the CTDI in the Technical Reference or User Manual. |
| Root 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.