FDA recalls BrightView SPECT systems

Editor's Note

The FDA has issued a Class I recall of Philips’ BrightView, BrightView X and BrightView XCT Single Photon Emission Computed Tomography (SPECT) scanners due to a component failure that could result in the system’s detector falling on patients.

Philips sent all affected customers an Urgent Medical Device Correction letter in December warning against positioning a patient's lower limbs directly under the detector, below the center of the gantry. Also, if the detector is above the center of the gantry and the detector support component fails, the detector will not be able to move to complete the imaging.

According to a report on DOTmed HealthCare Business News, Phillips stopped selling the X and XCT versions in in 2014, and the company decided to notify authorities about the risk despite no reports of patient injuries or deaths.

The report also notes that the recall was issued shortly after Philips signed a consent decree with the US Department of Justice for restoring compliance in its Respironics business after a 2021 ventilator recall associated more than 500 reported deaths.  Under the terms of that agreement, the company no longer sells sleep and respiratory care devices in the US but continues to service those already in use.