In a recent blog post, it was reported that Philips has issued a Class I recall, the most serious type, for its BrightView SPECT imaging systems, including BrightView, BrightView X, and BrightView XCT. This recall was initiated due to a potential issue where the detector of the system might move downwards unexpectedly, caused by a possible failure of a component known as the lead screw.
This problem presents a significant risk as the falling detector could potentially come into contact with patients. The U.S. Food and Drug Administration (FDA) elaborated on the risk, stating that if the detector is positioned below the center of the system gantry, there is a danger of physical injuries such as abrasions, contusions, lacerations, or fractures to the patient’s lower limbs. Moreover, the malfunction can interrupt the normal operation of the system. Even if the detector is above the center of the gantry, the operation of the system could still be affected.
Philips’ decision to issue this safety notice was prompted by a single complaint received in 2023, identified during post-market surveillance activities. Notably, there have been no reports of patient harm related to this issue. Philips ceased the production and sale of the BrightView product family in 2014, following earlier complaints about similar issues with components falling. Currently, it is estimated that around 1,000 of these systems are still in use and could be impacted by this safety notice.
As a precautionary measure, Philips has advised customers not to position patients’ lower limbs directly under the detector when it is below the center of the gantry bore. Additionally, Philips may arrange for a field service engineer to visit and perform necessary corrections to the system.