Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
Check against the official notice below — it lists the full affected range.
Elekta Limited is recalling Elekta Unity and Philips Marlin radiation therapy software (versions R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, and R6.1.571) distributed in the United States and internationally. The software has a defect in its Treatment Session Manager Motion Monitoring feature that can cause a misalignment between the overlay of organ contours and the actual motion monitoring images displayed during treatment for certain anatomical areas including the abdomen, head and neck, pelvis, and thorax. A total of 26 units were affected by this issue.
The recall notice does not specify what actions affected consumers or facilities should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images of the monitored structure.
Reason for recall: In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images of the monitored structure. Distribution: US distribution to IA, NY, PA, TX, WI. International distribution to Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Turkey, United Kingdom. Quantity: 26 units Lot/code info: Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571. UDI Number 05060191071321. Anatomy (Protocol Name): Abdomen (btFFE Cor RealTime, btFFE Cor Sag RealTime, btFFE Cor Sag Tra RealTime, btFFE Fast Sag Cor RealTime, btFFE Sag RealTime); HeadNeck L (bFFE Cor RealTime, bFFE Cor Sag RealTime, bFFE Cor Sag Tra RealTime, bFFE Sag RealTime, bFFE Sag Tra RealTime); HeadNeck M (bFFE Cor RealTime, bFFE Cor Sag RealTime, bFFE Cor Sag Tra RealTime, bFFE Sag RealTime, bFFE Sag Tra RealTime); Pelvis L (bFFE Cor RealTime, bFFE Cor Sag RealTime, bFFE Cor Sag Tra RealTime, bFFE Sag RealTime, bFFE Sag Tra RealTime); Pelvis M (bFFE Cor RealTime, bFFE Cor Sag RealTime, bFFE Cor Sag Tra RealTime, bFFE Sag RealTime, bFFE Sag Tra RealTime); Thorax (btFFE Cor RealTime, btFFE Cor Sag RealTime, btFFE Cor Sag Tra RealTime, btFFE Sag RealTime, btFFE Sag RealTime)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.