The U.S. Food and Drug Administration (FDA) has issued a warning letter to specialty CT manufacturer Xoran Technologies for violations related to its xCAT IQ, xCAT XL, MiniCAT 2020, and MiniCAT IQ devices.
The FDA said that design modifications to the company’s xCAT IQ and xCAT XL CT scanners need to be addressed in a special 510(k) submission to ascertain their impact on safety and effectiveness, according to a letter posted January 14.
“The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed,” the agency said.
For instance, in the company’s xCAT XL portable CT scanner, there’s been a possible change in scattered radiation due to the removal of gantry shields and a change in filters may affect scattered or leakage radiation, the FDA noted.
The FDA also noted that Xoran violated requirements by not ensuring that two of its suppliers validated soldering processes used to manufacture printed circuit boards (PCBs) for the company’s MiniCAT 2020 and MiniCAT IQ scanners.
“Over the last two years, there have been at least four confirmed complaints of PCB failures which required earlier-than-expected replacement of these boards within two years of installation,” the FDA said.
Over the last four years, 121 MiniCAT 2020 devices and 83 MiniCAT IQ devices were assembled with unvalidated PCBs from at least one or both of the suppliers and there are currently 156 MiniCAT 2020 devices and 175 MiniCAT IQ devices installed in the field with unvalidated PCBs, the FDA said.
Xoran is no longer using one of the suppliers but did not provide any details on whether it assessed the risk of using PCBs in existing inventory as well as in the field, according to the letter.