Due to potential patient safety concerns, Philips has announced a recall of it’s BrightView SPECT (single-photon emission computed tomography) imaging device in both the X and XCT versions.
The system’s detector could move downward under certain circumstances, thanks to the failure of a screw which could lead the device to fall on a patient. The U.S. Food and Drug Administration has designated this as a Class I recall, which is the most serious level of recall. It means that the issue could result in “serious adverse health consequences or death.”
In its notice issued Feb. 2, the FDA said, “If the detector is positioned below center of gravity, 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. If the detector is positioned above the center of gravity, there may be an interruption to normal system operation.”
In December, Philips first started notifying customers about the potential danger. It was in response to one complaint the company received in 2023 as part of its regular surveillance activities. No patients have been injured or harmed.
“The BrightView systems may continue to be used in accordance with their instructions for use and the instructions in the field safety notice,” Philips said in an email sent to the media. “Philips is contacting customers to schedule an inspection of the system. Implementation of an additional safety mechanism, and if necessary, replacement of the leadscrew.”
Headquartered in Amsterdam, Philips stopped producing and selling the BrightView SPECT family of produces in 2014. The safety notice will cover the remaining 1,000 imaging systems that are still being used. A Class II recall notice was announced by the Australian Therapeutic Goods Administration in January as well.
Customers have been instructed by Philips not to position patients’ lower limbs directly under the detector below the center of the gantry bore. Device owners are encouraged to contact the Philips customer care solutions center at 800-722-9377.
If you have questions about your medical imaging equipment, don’t hesitate to reach out to the experts at Atlantis Worldwide.
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Meet the author: Vikki Harmonay
