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RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden Recalls

All product recalls associated with RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden.

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Recall Summary

Total Recalls

39

Past Year

0

Class I (Serious)

0

Most Recent

Jun 2022

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–39 of 39 recalls

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation 8B Service Pack 2, UDI # 07350002010235 - Pro...

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.

FDAMay 18, 2020Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation 9B, UDI # 07350002010266 - Product Usage: For...

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.

FDAMay 18, 2020Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation 6 Service Pack 3, UDI # 07350002010242 - Produ...

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.

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FDAMay 18, 2020Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation 8B Service Pack 1, UDI # 07350002010204 - Pro...

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.

FDAMay 18, 2020Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation 9A, UDI # 07350002010174 - Product Usage: For...

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.

FDAMay 18, 2020Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation 5 Service Pack 3, UDI # 07350002010020 - Produ...

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.

FDAMay 18, 2020Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation 6 Service Pack 2, UDI # 07350002010075 - Prod...

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.

FDAMay 18, 2020Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation 8A Service Pack 1, UDI # 07350002010136 - Pro...

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.

FDAMay 18, 2020Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation 6, UDI # 07350002010013 - Product Usage: For r...

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.

FDAMay 18, 2020Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation 6 Service Pack 1, UDI #s 07350002010037, 0735...

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.

FDAMay 18, 2020Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation standalone software treatment planning system,...

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.

FDAMar 4, 2020Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1....

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.

FDAFeb 20, 2020TN• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation/RayPlan 8A, Build Number 8.0.0.61, stand-alone...

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.

FDAFeb 20, 2020TN• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1....

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.

FDAFeb 20, 2020TN• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alon...

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.

FDAFeb 20, 2020TN• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone...

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.

FDAFeb 20, 2020TN• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alon...

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.

FDAFeb 20, 2020TN• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation stand-alone software treatment planning system...

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.

FDADec 19, 2019Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation stand-alone software treatment planning system...

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.

FDANov 18, 2019Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden