FDA issues Class I recall notice for Philips nuclear imaging system
Philips has launched a voluntary recall of a years-old nuclear imaging system due to potential patient safety concerns, the U.S. Food and Drug Administration announced recently.
The recall pertains to the BrightView SPECT (single-photon emission computed tomography) device, including the X and XCT versions. Under certain circumstances, the system’s detector may move downward due to a screw failure, with the potential to fall on a patient. Federal officials designated this as a Class I recall, the FDA’s most serious, meaning the issue poses the danger of “serious adverse health consequences or death.”
“If the detector is positioned below 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,” the FDA said in its notice, issued Feb. 2. “If [the ]detector is positioned above center of gantry, there may be an interruption to normal system operation,” the agency added.
Philips first began notifying customers about the potential issue in December. The field safety notice was the result of one complaint the company received last year as part of its regular surveillance activities. There have been zero reports of patient injury or harm.
“The BrightView systems may continue to be used in accordance with their instructions for use and the instructions in the field safety notice,” the company said in an email to members of the media Monday. “Philips is contacting customers to schedule an inspection of the system, implementation of an additional safety mechanism, and if necessary, replacement of the leadscrew.”
The Amsterdam-headquartered manufacturer stopped producing and selling the BrightView SPECT family of products in 2014, with the safety notice covering the remaining 1,000 imaging systems still in use. The Australian Therapeutic Goods Administration also issued its own Class II recall notice Jan. 30.
Philips has instructed customers not to position patients’ lower limbs directly under the detector below the center of the gantry bore. Providers are urged to circulate the notice to all device users and keep the letter near impacted imaging systems until the correction is complete.
Those with questions can call Philips customer care solutions center at 800-722-9377.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.