Company: RAYSEARCH LABORATORIES AB
Date of Enforcement Report: 6/17/2020
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
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
RAYSEARCH LABORATORIES AB on 5/18/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE