Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 6/17/2020 Class II PRODUCT RayStation 4.0 to RayStation 5 Service Pack 2 – Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. Recall Number: Z-2339-2020 REASON Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS)...Read More

Company: Elekta Limited Date of Enforcement Report: 6/17/2020 Class II PRODUCT Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571 Recall Number: Z-2297-2020 REASON 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...Read More

Company: Philips Healthcare Informatics, Inc. Date of Enforcement Report: 6/17/2020 Class II PRODUCT IntelliSpace PACS 4.4, Product number 837507 – Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. Recall Number: Z-2338-2020 REASON Images may potentially become corrupt while using the system. RECALLING FIRM/MANUFACTURER Philips...Read More