The U.S. Food and Drug Administration (FDA) has issued a Class I recall for Philips' BrightView SPECT scanners due to a potential component failure that could result in injury to patients.
“If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patient's lower limbs, as well as an interruption to normal system operation. If detector is positioned above center of gantry, there may be an interruption to normal system operation,” the FDA said, in its recall notice.
Philips notified customers of the potential problem on December 15, 2023, with a notice stating field service engineers would be visiting sites to correct the system if necessary.
Philips stopped producing and selling the BrightView product family in 2014, according to the company. The recall notice includes the BrightView, BrightView X, and BrightView XCT versions of the SPECT scanner. To date, no patient injuries have been reported.
