Company: Heimann Systems Corporation
Product: Cabinet x-ray system
Date: 10/30/2002
21 CFR 1020.40(c)(10) requires that x-ray systems designed for security screening of carried possessions in public facilities shall be provided with means to insure operator presence at the control area in a position which permits surveillance of the ports during generation of x-radiation. We observed that this system was installed in a public area of an office building and did not require the operator to be present to produce x-rays. The conveyor forward and backward buttons could be pressed once and the conveyor would continue to operate. This allowed x-ray generation to take place when an object was placed on the conveyor and passed through the system even with no one present.
FDA District: Center for Devices and Radiological Health (CDRH)
