Hundreds of radiation therapy systems subject to FDA recall

A Class 2 recall has been issued for radiation therapy systems due to a software glitch that could impact treatment accuracy. 

Developed by Philips, the Pinnacle Radiation Therapy Treatment Planning System is a software program used by dosimetrists and medical physicists to design radiation therapy treatment plans. The software supports photon, proton, and electron beam therapy and was designed to maximize treatment efficacy while also sparing healthy tissue surrounding tumors. 

The system’s recall is related to software issues that could skew collimation of a treatment region of interest, causing the targeted ROI to be either bigger or smaller than intended. 

“Due to a software issue, there is a potential image error of the region of interest for expansion/contraction for HFP (head first prone), FFS (feet first supine) and FFP (feet first prone) orientations,” a notice from U.S. Food and Drug Administration reads. 

In August, Philips sent affected customers an Urgent Medical Device Correction letter indicating that the system will always assume the patient is in the head first supine (HFS) position when transposing the advanced expansion to alternate positions. For this reason, Philips recommends consumers using the system’s Advanced ROI Expansion and Contraction feature, only use the HFS patient orientation. 

The company assures affected customers they will be contacted by a field service engineer to set up a time to install a solution. In the meantime, Philips has requested that users post the correction letter they were issued in a place where it is likely to be seen to ensure operators are aware of the glitch.  

The recall affects 810 system distributed throughout the U.S. For more information, read the full recall notice here.