Medical DeviceAug 4, 2021
RAYSEARCH LABORATORIES AB RayStation recall — FDA Z-2138-2021
Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Recall history in this database
Classification mix: Class II: 90.
Medical DeviceJun 16, 2021
RAYSEARCH LABORATORIES AB RayStation recall — FDA Z-1838-2021
Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after editing the clinical goal. It also describes an issue with contouring when the spacing…
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceMay 26, 2021
RAYSEARCH LABORATORIES AB RayStation standalone software radiation therapy treatment recall — FDA Z-1598-2021
When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the…
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceMay 26, 2021
RAYSEARCH LABORATORIES AB RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B recall — FDA Z-1597-2021
For some LINAC types, merging clinical beams with beams of approximate dose may lead to the approximate dose erroneously labeled as clinical dose. Merge beams can be used manually, in…
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceApr 21, 2021
RAYSEARCH LABORATORIES AB RayStation recall — FDA Z-1427-2021
Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.
Class IIFDA: OngoingRAYSEARCH LABORATORIES AB
Medical DeviceMar 31, 2021
RAYSEARCH LABORATORIES AB RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology recall — FDA Z-1281-2021
Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later
Class IIFDA: OngoingRAYSEARCH LABORATORIES AB
Medical DeviceDec 23, 2020
RAYSEARCH LABORATORIES AB RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1 recall — FDA Z-0589-2021
Two issues were found with the treatment plan report: 1) There may be incorrect information for the percent of a region of interest with a clinical goal that is outside the dose grid; and…
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceDec 2, 2020
RAYSEARCH LABORATORIES AB RayStation standalone software treatment planning system, Model recall — FDA Z-0478-2021
If a region of interest (ROI) or point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure Set, the reference may become linked to the wrong…
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceSep 2, 2020
RAYSEARCH LABORATORIES AB RayCare, device is stand-alone software - Product Usage: used to recall — FDA Z-2899-2020
When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the treatment image related to the…
Class IIFDA: OngoingRAYSEARCH LABORATORIES AB
Medical DeviceJul 1, 2020
RAYSEARCH LABORATORIES AB RayStation standalone software treatment planning system recall — FDA Z-2426-2020
It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the…
Class IIFDA: OngoingRAYSEARCH LABORATORIES AB
Medical DeviceJun 17, 2020
RAYSEARCH LABORATORIES AB RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage recall — FDA Z-2342-2020
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.
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceJun 17, 2020
RAYSEARCH LABORATORIES AB RayStation 8A Service Pack 1, UDI # 07350002010136 - Product recall — FDA Z-2345-2020
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.
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceJun 17, 2020
RAYSEARCH LABORATORIES AB RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage recall — FDA Z-2340-2020
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.
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceJun 17, 2020
RAYSEARCH LABORATORIES AB RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage recall — FDA Z-2343-2020
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.
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceJun 17, 2020
RAYSEARCH LABORATORIES AB RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation recall — FDA Z-2349-2020
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.
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceJun 17, 2020
RAYSEARCH LABORATORIES AB RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation recall — FDA Z-2346-2020
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.
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceJun 17, 2020
RAYSEARCH LABORATORIES AB RayStation 9B Service Pack 1, UDI # 07350002010297 - Product recall — FDA Z-2351-2020
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.
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceJun 17, 2020
RAYSEARCH LABORATORIES AB RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation recall — FDA Z-2344-2020
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.
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceJun 17, 2020
RAYSEARCH LABORATORIES AB RayStation 7, UDI # 07350002010068 - Product Usage: For radiation recall — FDA Z-2353-2020
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.
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceJun 17, 2020
RAYSEARCH LABORATORIES AB RayStation 8B Service Pack 2, UDI # 07350002010235 - Product recall — FDA Z-2348-2020
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.
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceJun 17, 2020
RAYSEARCH LABORATORIES AB RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For recall — FDA 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.
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceJun 17, 2020
RAYSEARCH LABORATORIES AB RayStation 6, UDI # 07350002010013 - Product Usage: For radiation recall — FDA Z-2341-2020
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.
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceJun 17, 2020
RAYSEARCH LABORATORIES AB RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation recall — FDA Z-2350-2020
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.
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceJun 17, 2020
RAYSEARCH LABORATORIES AB RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 recall — FDA Z-2352-2020
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.
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Understanding this recall history
This page summarizes recall records in which the official source identifies RAYSEARCH LABORATORIES AB as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.