The Recall Desk

Manufacturer

RAYSEARCH LABORATORIES AB

115 recalls in our database name RAYSEARCH LABORATORIES AB as the manufacturing or recalling firm.

What the numbers show

Total
115
Critical
1
Severe
9
Most recent
2026-07-08

Of the 115 recalls from RAYSEARCH LABORATORIES AB we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (8%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

76–100 of 115

  • HighFDA (Devices)·Z-2352-2020·2020-06-17

    RayStation 6 Service Pack 1 Radiation Therapy Software Recall

    RaySearch Laboratories is recalling RayStation 6 Service Pack 1 software due to a calculation error that may underestimate radiation dose.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2343-2020·2020-06-17

    RayStation 6 Service Pack 3 Radiation Therapy Software Recall

    RaySearch Laboratories is recalling RayStation 6 Service Pack 3 software due to a calculation error that could underestimate radiation dose.

    Product
    RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1598-2020·2020-04-01

    RayStation software recall due to virtual wedge field limitations

    RaySearch Laboratories is recalling RayStation software because virtual wedge fields may not cover the entire field, resulting in a high dose plateau.

    Product
    RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. Aft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1462-2020·2020-03-18

    RayStation 8A Software Recalled for Treatment Planning Calculation Errors

    RaySearch Laboratories is recalling RayStation/RayPlan 8A software due to a defect that causes incorrect treatment planning values when pitch or roll corrections are applied.

    Product
    RayStation/RayPlan 8A, Build Number 8.0.0.61, stand-alone software treatment planning system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1467-2020·2020-03-18

    RayStation 9A Software Recall for Pitch and Roll Correction Errors

    RaySearch Laboratories is recalling one RayStation/RayPlan 9A system in Tennessee due to potential errors in position propagation when pitch or roll corrections are applied.

    Product
    RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment planning system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1465-2020·2020-03-18

    RayStation 8B Software Recalled for Pitch and Roll Correction Errors

    RaySearch Laboratories is recalling one RayStation 8B treatment planning system in Tennessee due to a software error that may cause incorrect position values.

    Product
    RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatment planning system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1468-2020·2020-03-18

    RayStation 9B Software Recalled for Pitch and Roll Correction Errors

    RaySearch Laboratories AB is recalling one RayStation/RayPlan 9B software system in Tennessee due to potential errors in position calculations during pitch or roll corrections.

    Product
    RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1464-2020·2020-03-18

    RayStation 8B Software Recalled for Pitch and Roll Correction Errors

    RaySearch Laboratories AB is recalling one RayStation 8B software system in Tennessee due to potential errors in tabletop position propagation.

    Product
    RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1466-2020·2020-03-18

    RayStation 8B Software Recalled for Pitch and Roll Correction Errors

    RaySearch Laboratories is recalling one RayStation 8B software system in Tennessee due to a defect that causes incorrect position values when pitch or roll corrections are applied.

    Product
    RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1463-2020·2020-03-18

    RayStation Software Recall for Potential Treatment Planning Errors

    RaySearch Laboratories is recalling one RayStation 8A system in Tennessee due to a software defect that may cause incorrect treatment planning calculations.

    Product
    RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0866-2020·2020-02-05

    RayStation Treatment Planning Software Recalled for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation software due to defects that may cause incorrect dose calculations during treatment planning.

    Product
    RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0736-2020·2020-01-01

    RayStation Radiation Therapy Software Recalled for Beam Editing Bug

    RaySearch Laboratories is recalling RayStation software versions 4.0 through 9.0 because a bug may reset beam settings, requiring dose recalculation.

    Product
    RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 - Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1930-2019·2019-07-10

    RaySearch Recalls Radiation Therapy Planning Software Due to Dose Calculation Errors

    RaySearch Laboratories AB is recalling RayStation and RayPlan software versions because electron Monte Carlo dose calculations may be incorrect when using a very large number of histories.

    Product
    RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatment planning and analysis of radiation therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0679-2019·2019-01-02

    RayStation Software Versions Recalled for Dose Tracking Coordinate Errors

    RaySearch Laboratories is recalling specific RayStation software versions because isocenter shifts in dose tracking are incorrectly interpreted.

    Product
    RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-0294-2019·2018-11-07

    RayStation Software Recalled for Unsupported Robust Optimization Feature

    RaySearch Laboratories AB is recalling RayStation software versions 4.5 through 7 because robust optimization for specific plans is not supported.

    Product
    RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2554-2018·2018-08-01

    RayStation Radiation Therapy Software Recalled for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation software due to erroneous beam profile parameters that may cause incorrect dose calculations in large or off-axis fields.

    Product
    RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0 Product Usage RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2497-2018·2018-07-25

    RayStation Software Recalled for Potential Radiation Overdose Risk

    RaySearch Laboratories is recalling RayStation treatment planning software versions 4.5 through 8A because a calculation error could lead to significant radiation overdosage during therapy.

    Product
    RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8A (RayPlan 8A) Product Usage: RayStation is a software system designed for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2290-2018·2018-07-04

    RayStation Radiation Therapy Software Recalled for Dose Calculation Accuracy Issues

    RaySearch Laboratories is recalling RayStation Radiation Therapy Treatment Planning System software versions 6.0 through 7.0 because dose calculation accuracy may be less than expected in some situations.

    Product
    RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1275-2018·2018-04-04

    Ray Station Software Recalled for Potential Incorrect Radiation Treatment Volume

    RaySearch Laboratories is recalling Ray Station 4.9 through 7 software due to a defect that may result in incorrect treatment volumes being delivered to patients.

    Product
    Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19 UDI: 0735000201006820171130
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0380-2018·2018-01-24

    RayStation 6 Proton QA Module Recall for Potential Dosage Errors

    RaySearch Laboratories is recalling RayStation 6 software due to a defect in the proton QA module that may result in incorrect patient dosage calculations.

    Product
    RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to admin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1815-2017·2017-04-19

    RayStation Radiation Therapy Software Recalled for GPU Driver Error

    RaySearch Laboratories is recalling RayStation software due to a potential calculation error in non-standard Citrix environments.

    Product
    Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0720-2017·2016-12-14

    RayStation 5.0 Radiation Therapy Software Recalled for Dose Display Error

    RaySearch Laboratories is recalling RayStation 5.0 software due to a potential error in dose display on auxiliary CT images, which could result in incorrect treatment planning data.

    Product
    Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0721-2017·2016-12-14

    RayStation Radiation Therapy Software Recalled for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation software versions 4.0, 4.5, 4.7, and 5.0 due to potential inaccuracies in proton dose calculations for specific treatment plans.

    Product
    RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0079-2017·2016-10-19

    RaySearch Radiation Therapy Treatment Planning System Software Recall

    RaySearch Laboratories is recalling Model 5.0 software due to a bug that may display incorrect dose statistics in treatment plan reports.

    Product
    Radiation Therapy Treatment Planning System, Model 5.0
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0038-2017·2016-10-12

    RayStation Radiation Therapy Planning Software Recalled for Dose Calculation Errors

    RaySearch is recalling RayStation software versions 2.5 through 5.0 due to dose calculation errors when using specific region of interest settings.

    Product
    RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters an
    Category
    Medical Device
    Distribution
    Distributed nationwide