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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

RAYSEARCH LABORATORIES AB: 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.

Agency Publication Date: March 10, 2020
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Affected Products

Product: RayStation/RayPlan 8A, Build Number 8.0.0.61, stand-alone software treatment planning system

UDI 07350002010112

Product: RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system

UDI 07350002010136

Product: RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system

UDI 07350002010129

Product: RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatment planning system

UDI 07350002010204

Product: RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system

UDI 07350002010235

Product: RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment planning system

UDI 07350002010174

Product: RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system

UDI 07350002010266

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85065
Status: Resolved
Manufacturer: RAYSEARCH LABORATORIES AB
Manufactured In: Sweden
Units Affected: 7 products (1 system; 1 system in the U.S.; 1 system in the U.S.; 1 system in the U.S.; 1 system in the U.S.; 1 system in the U.S.; 1 system in the U.S.)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.