RAYSEARCH LABORATORIES AB: 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.

Agency Publication Date: June 10, 2020

Affected Products

Product: 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.

Build numbers: 4.0.3.4, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 5.0.1.11, 5.0.2.35,

Product: RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

UDI # 07350002010020 Build number: 5.0.3.17

Product: RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

UDI # 07350002010013 Build number: 6.0.0.24

Product: RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

UDI # 07350002010075 Build number: 6.2.0.7

Product: RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

UDI # 07350002010242 Build number: 6.3.0.6

Product: RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

UDI # 07350002010112 Build number: 8.0.0.61

Product: RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

UDI # 07350002010136 Build number: 8.0.1.10

Product: RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

UDI # 07350002010129 Build number: 8.1.0.47

Product: RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

UDI # 07350002010204 Build number: 8.1.1.8

Product: RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

UDI # 07350002010235 Build number: 8.1.2.5

Product: RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

UDI # 07350002010174 Build number: 9.0.0.113

Product: RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

UDI # 07350002010266 Build number: 9.1.0.933

Product: RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

UDI # 07350002010297 Build number: 9.2.0.483

Product: RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

UDI #s 07350002010037, 07350002010082 Build number: 6.1.1.2

Product: RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

UDI # 07350002010068 Build number: 7.0.0.19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85723

Status: Resolved

Manufacturer: RAYSEARCH LABORATORIES AB

Manufactured In: Sweden

Were You Affected by This Recall?

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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.