FDA
ZAP-X Radiosurgery System
Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to 1.5 degrees) rotational deviations, between digitally reconstructed radiographs, and pre-delivery X-ray images. In these cases the transitional alignment algorithm may incorrectly calculate the new treatment table offset values, leading to an incorrect position for the subsequent treatment isocenter.
On 7/05/22 correction notices were distributed to customers who were told that revised software to address the recall issue would be supplied. Until the firm supplies the revised software follow the following steps to ensure accurate treatment delivery:
1) After using auto-align ensure initial patient setup (prior to treating the first isocenter), has rotational deviations of less than plus-minus 1.5 degrees in each dimension.
2) Prior to commencement of each isocenter beam delivery, verify that rotational deviations remain below plus-minus 1.5 degrees.
- Additionally, visually verify patient alignment using image overlay before each subsequent isocenter.
3) Use "auto-align" in cases where the observed rotation deviations exceed plus-minus 1.5 degrees. This will correct the offset to within specifications.
4) Be reminded of the following warning message from IFU E0920-00004 Rev. G Page 49:
"Warning: Safe and effective treatment requires accurate patient positioning. It is your responsibility to confirm the final alignment. Carefully observe the KV image and it's correction to the DRR image."
The software correction will:
- Correct the defect in the transitional alignment algorithm.
- Revise the user interface to provide the capability to trend computed rotations in real time during treatment, to better aid the user in identifying possible alignment errors.
Customers with additional questions can contact the firm at +1 (408) 933-8477, Derek@zapsurgical.com