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RAYSEARCH LABORATORIES AB Recalls
115 recalls on record · September 12, 2012 to July 8, 2026 · Medical Devices
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 2, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical i
Hazard: 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 fraction and the planning image selected. When starting the task, an error message might be displayed stating: Review files not available.
July 1, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) mo
Hazard: 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 display of planned and recorded Gantry Angle in the delivered beam list in RayTreat.
June 17, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology which can also be used t
Hazard: 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.
June 17, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation therapy and medical
Hazard: 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.
June 17, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which ca
Hazard: 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.
June 17, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used
Hazard: 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.
June 17, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used
Hazard: 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.
June 17, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which ca
Hazard: 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.
June 17, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medical oncology which ca
Hazard: 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.
June 17, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used
Hazard: 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.
June 17, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which ca
Hazard: 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.
June 17, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used t
Hazard: 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.
June 17, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can
Hazard: 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.
June 17, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can
Hazard: 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.
June 17, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which can also be used to
Hazard: 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.
June 17, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can
Hazard: 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.
June 17, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology which can also
Hazard: 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.
April 1, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0
Hazard: Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtual Wedge fields recommended by the LINAC vendor will be more restricted in the wedged direction than the maximum field opening without a wedge. Delivering a larger field opening with a virtual wedge will not result in a wedged field shape over the entire field. Instead, a high dose plateau region will be the result at the toe side of the field beyond the recommended field size.
March 18, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system
Hazard: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
March 18, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment planning system
Hazard: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
March 18, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system
Hazard: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
March 18, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatment planning system
Hazard: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
March 18, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system
Hazard: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
March 18, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system
Hazard: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
March 18, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation/RayPlan 8A, Build Number 8.0.0.61, stand-alone software treatment planning system
Hazard: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
February 5, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0,
Hazard: Three issues found: i) The Map ROI options in the ROI list in the Structure Definition module may generate unintended ROI geometries ii) Elekta guard leaf behavior. There is an interoperability issue with Elekta regarding setting of guard leaves. iii)SSD, when intended as source-to-surface distance, it sometimes gives source-to-skin distance.To the best of our knowledge, these issues have not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect dose calculations during treatment planning.
January 1, 2020Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.
Hazard: Editing a static arc beam may unexpectedly set the MU of the beam to its initial default value of 200 MU. If the bug is triggered, the dose is invalidated and needs to be recalculated before the plan can be approved or exported.
July 10, 2019Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) a
Hazard: When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong
January 2, 2019Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation
Hazard: Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A. In these versions, isocenter shifts in dose tracking are incorrectly interpreted according to the DICOM patient coordinate system.
November 7, 2018Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning
Hazard: Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7.