Recall Z-0782-2011 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare, LLC
HiSpeed FX/I (2200997-2 with Gantry mo. #2249696-2)
| Date | Jan 4, 2011 (initiated Feb 1, 2010) |
| Status | Terminated |
| Reason | A defect with the hardware and software displaying the incorrect dose data. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to |
| Quantity | 102 total |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.