Philips has initiated a Class I recall, the most serious category, for its BrightView SPECT imaging systems due to a potential hazard where a component might fail and cause the detector to unexpectedly move downward, posing a risk of injury to patients. This issue, reported in December 2023, affects the BrightView, BrightView X, and BrightView XCT models. The concern arises particularly when the detector is positioned below the center of the system gantry, which could lead to abrasions, contusions, lacerations, fractures to the patient’s lower limbs, or disrupt normal system operations. The FDA highlighted the risk of the detector unexpectedly falling due to component failure, emphasizing the potential injuries to patients and interruptions in system functioning.
This recall was prompted by a single complaint received in 2023, part of Philips’ post-market surveillance. Despite the complaint, there have been no reported instances of patient harm. Philips discontinued the production and sale of the BrightView product family in 2014, following similar issues, but estimates that around 1,000 units could still be in operation and thus, subject to this recall. Philips has advised customers to avoid positioning patients’ lower limbs directly under the detector and may arrange for field service engineers to visit and make necessary corrections to the systems.