The Recall Desk

FDA (Devices) recall action 94388

RAYSEARCH LABORATORIES AB recalled 12 products on 2024-05-08

The FDA (Devices) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.

Products
12
Announced
2024-05-08
Critical
0
Units
589

Why these products were recalled

Potential for reported SSD to be too high.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–12 of 12

  • HighFDA (Devices)··2024-05-08

    RayStation Radiation Therapy Planning Software Recalled for Calculation Error

    RayStation radiation therapy planning software versions 10.0.0.1154, 10.0.1.52, and 10.0.2.10 have been recalled due to a potential calculation parameter issue that could affect treatment planning. The FDA classified this as a Class II recall affecting 213 units worldwide.

    Product
    RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-05-08

    RayStation 7.0.0.19 radiation therapy planning software recalled for dose calculation error

    RayStation 7.0.0.19, a radiation therapy treatment planning system, is being recalled due to potential source-to-surface distance (SSD) calculation errors that could affect radiation dose accuracy. The recall affects 14 units distributed worldwide.

    Product
    RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-05-08

    Radiation Therapy Planning System May Calculate Skin Surface Distance Incorrectly

    RayStation radiation therapy planning software versions 11.0.0.951, 11.0.1.29, 11.0.3.116, and 11.0.4.15 may calculate skin surface distance (SSD) values incorrectly, potentially affecting dose calculations. Affected software has been distributed worldwide.

    Product
    RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-05-08

    Radiation therapy planning system may report overly high skin surface doses

    RayStation versions 8.0.0.61 and 8.0.1.10 are subject to a Class II FDA recall due to a potential for calculated skin surface doses to be reported as too high. Healthcare facilities using these versions should contact the manufacturer for guidance and a corrective update.

    Product
    RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-05-08

    RayStation radiation therapy planning system may report inaccurate dosimetry values

    RayStation 14.0.0.3338, a radiation therapy treatment planning system, may report source-to-surface distance (SSD) values as higher than actual measurements, potentially affecting radiation dose calculations. The FDA Class II recall involves 49 units distributed worldwide.

    Product
    RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-05-08

    Radiation therapy planning system may calculate patient doses too high

    RayStation versions 10.1.0.613 and 10.1.1.54 may calculate radiation doses higher than intended. Eighteen units have been distributed worldwide to medical facilities.

    Product
    RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-05-08

    Radiation therapy planning system dose calculation error

    RayStation versions 9.1.0.933 and 9.2.0.483 may incorrectly calculate dose parameters. 11 units of this radiation therapy treatment planning software were distributed worldwide.

    Product
    RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-05-08

    RayStation Radiation Therapy System Recalled for Potential Dosing Error

    RayStation versions 13.0.0.1547, 13.1.0.144, and 13.1.1.89 radiation therapy treatment planning systems are recalled due to a potential software error in source-to-surface distance calculations that could affect radiation dose delivery.

    Product
    RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-05-08

    Radiation Therapy Planning System May Report Dose Values Too High

    RayStation radiation therapy planning software versions 9.0.0.113 and 9.0.1.142 may report dose values that are higher than actual. The Class II recall affects 63 units distributed worldwide.

    Product
    RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-05-08

    RayStation radiation therapy system dosing parameter recall

    RayStation 15.0.0.430 radiation therapy planning system may have an elevated SSD parameter. Users should contact Raysearch Laboratories AB for corrective guidance.

    Product
    RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-05-08

    Radiation therapy planning system doses may be calculated incorrectly

    Certain versions of RayStation radiation therapy planning software may incorrectly report dose-related parameters, potentially affecting treatment calculations. The manufacturer recommends verification of affected systems.

    Product
    RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Planning System.
    Category
    Distribution
    0 states