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RaySearch America Recalls
2 recalls on record · April 6, 2022 to July 5, 2023 · Medical Devices
Recalls by year
22
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 5, 2023Medical DevicesFDA
RaySearch America Inc recalls Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2,
Hazard: A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function or ROI algebra function, the results are incorrect. If dose statistics for an incorrectly created ROI are used to determine if a plan is acceptable for treatment, this could potentially lead to an inappropriate plan being approved. The error could lead to a more conservative or more liberal plan than intended.
April 6, 2022Medical DevicesFDA
RaySearch America Inc recalls RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) to RayStation 5 Ser
Hazard: Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.