Philips has issued a voluntary recall of its BrightView SPECT nuclear imaging system due to potential patient safety concerns. The recall was prompted by a screw failure in the system's detector, which under certain circumstances may move downward and potentially fall on a patient. The issue has been designated as a Class I recall by the FDA, meaning it poses the risk of serious adverse health consequences or death. While no patient injuries or harm have been reported, Philips is contacting customers to schedule inspections and implement additional safety measures or replacements if necessary. The recall notice covers the remaining 1,000 imaging systems still in use, as the BrightView SPECT family of products ceased production and sales in 2014. Providers are advised not to position patients' lower limbs directly under the detector below the center of the gantry bore.
Tue, 06 Feb 2024 21:17:46 GMT | Radiology Business