Recall Atlas

RaySearch recalls

2 official recalls and safety alerts involving RaySearch since 2022-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with RaySearch or the relevant agency.

  1. 2023-07-05
  2. US
    Drugs & medicalClass II

    RaySearch America Inc recalls Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1,…

    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…

    FDA · DeviceRaySearch America IncUS: AZ, CA, GA & WAOfficial notice →
  3. 2022-04-06
  4. US
    Drugs & medicalClass II

    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 Service Pack 2…

    Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.

    FDA · DeviceRaySearch America IncUS Nationwide distribution in the states of AK, AL, AR, AZ, CA, CT, DC, DE,…Official notice →