The FDA issued a Class I recall — the most serious kind — for the Philips
(NYSE: PHG)
BrightView SPECT imaging systems.
In December 2023, Philips notified customers about a potential issue with BrightView systems (including BrightView, BrightView X and BrightView XCT). Under specific circumstances, the detector may move downward due to a potential component (lead screw) failure. This comes with a risk of contacting the patients, according to a Philips spokesperson.
The FDA described the issue by saying the “detector may unexpectedly fall due to a component failure.” According to the agency, if a detector is positioned below center of the system gantry, there is the 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 still could be an interruption to normal system operation.
According to Philips, the safety notice came as the result of one single complaint on the issue received in 2023. It came as part of Philips’ post-market surveillance activities. The company received no report of patient harm. Philips stopped producing and selling the BrightView product family in 2014, shortly after complaints of similar falling component scenarios. The company estimates that approximately 1,000 systems remain in use and could be affected by the safety notice.
Philips told customers to not position a patient’s lower limbs directly under the detector below the center of gantry bore. The company may schedule a field service engineer to visit the site and correct the system if necessary.
See also: a full timeline of Philips’ long-running Class I respiratory device recall