Philips has recalled its BrightView SPECT imaging systems for a potential component failure that would cause part of the device to fall on the patient. The recall affects the BrightView, BrightView X, and BrightView XCT detectors and is considered a class 1 recall by the U.S. FDA, the most serious type of recall, indicating that use of these devices may cause serious injuries or death.
According to FDA recall filing, if the detector is positioned below the 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 the detector is positioned above the center of the gantry, there may be an interruption to normal system operation.
In December, Philips notified affected customers through Urgent Medical Device Correction letters. Customers were instructed to not position a patient’s lower limbs directly under the detector below the center of the gantry bore. Customers are expected to circulate the notice to all users of the device for awareness and retain the letter with affected systems until the correction is complete.
Philips will contact customers to schedule a time for a Philips field service engineer to visit the customer site and correct the system if necessary.
