FDA issues recall on Philips spectral CT systems

Software issues with Philips’ spectral CT scanners have prompted the U.S. Food and Drug Administration to issue a device safety warning. 

The Class 2 recall was issued amid concerns the software glitch could cause adverse health consequences. There's risk the device may inadvertently move during imaging, making unintentional contact with patients or other equipment. 

“Devices with affected software may experience two unintended motion issues that may lead to contact between the gantry or table with the operator or patient,” the recall notice reads, adding that the issues also may affect other aspects of the scanner’s performance. 

Philips sent out an “Urgent Medical Device Correction" to customers on May 29. The notice explains how to recognize signs the spectral scanners may be malfunctioning. It also assures that the scanners can still be used, though corrective actions need to be taken to ensure safety.  

An appendix in the notice details 10 software issues, along with the recommended corrective actions. Providers are encouraged to submit a response form to Philips. The adjustments should address the issues temporarily, but a field engineer will need to visit the site to install additional software, Philips said. 

There are approximately 370 of the scanners operating globally. The systems are in use in 19 U.S. states. Affected customers are encouraged to contact Philips Customer Care Solutions at 800-722-9377. 

More detailed information on the affected devices can be found here.