Philips told users of its BrightView imaging machines the detector might fall because of a component failure. No injuries or deaths have been reported, the FDA said Feb. 15.
The BrightView machines use single photon emission computed tomography to take images of biological activity in the human body. If the machine's detector is above the center of gravity, clinical imaging will be interrupted. If it's below the center of gravity, the detector could fall "in an uncontrolled manner and contact the patient," the FDA said.
Clinicians are recommended to not position a patient's lower limbs directly under the BrightView detector.
The notice affects 553 BrightView, BrightView X and BrightView XCT machines, and Philips will contact customers to schedule a correction to the machines if necessary.
One incident has been reported.