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.

51–75 of 115

  • HighFDA (Devices)·Z-0848-2022·2022-04-06

    Radiation therapy planning software subject to jaw positioning errors during optimization

    RayStation radiation therapy planning software (versions 6-11A) may unexpectedly change jaw positions during optimization after dose or target modifications. Users should verify treatment plans carefully before delivery.

    Product
    TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0732-2022·2022-03-16

    Radiation therapy planning software displays wrong images during animation playback

    RayStation/RayPlan versions 6.0.0.24 through 9.2.0.483 incorrectly display selected images as both primary and secondary when animation playback is running, affecting treatment planning visualization.

    Product
    RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 . Includi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2138-2021·2021-08-04

    RayStation radiation treatment planning system positioning error recall

    RayStation versions 9A through 11A may set initial delivery positions incorrectly during setup beam localization. Five units are affected; no patient injuries reported.

    Product
    RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combination with RayCare Model Numbers/ UDI: RayStation 9.0 (9.0.0.113) 07350002010174; RayStation 9.1 (9.1.0.933) 07350002010266; RayStation 9.1 Service Pack 1 (
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1838-2021·2021-06-16

    Medical Device Software Defects in RayStation Treatment Planning System

    RayStation radiation therapy treatment planning software versions 6 through 10A contain defects that may cause misleading dose evaluations and contouring errors. Healthcare facilities should verify treatment plans and contact the manufacturer for guidance.

    Product
    RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154 , 10.0.1.52 or 10.1.0.613 .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1597-2021·2021-05-26

    RayStation Software Recall Due to Dose Labeling Error in Merged Beams

    RaySearch Laboratories is recalling RayStation and RayPlan software versions due to a defect that may mislabel approximate radiation doses as clinical doses.

    Product
    RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs. Standalone software treatment planning system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1598-2021·2021-05-26

    RayStation software recall due to incorrect total dose display

    RaySearch Laboratories is recalling RayStation software because the total dose display may be incorrect when using multiple plans in a treatment course.

    Product
    RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1427-2021·2021-04-21

    RayStation Software Recall Due to Potential Data Synchronization Errors

    RaySearch Laboratories is recalling RayStation software versions 9A, 9B, 10A, and 10B because flags edited in RayCare may not update in RayTreat.

    Product
    RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1281-2021·2021-03-31

    RayCare 3B Oncology Software Recalled for Data Loss During Upgrade

    RaySearch Laboratories AB is recalling RayCare 3B software because patient messages may be lost when upgrading from RayCare 2.

    Product
    RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0589-2021·2020-12-23

    RaySearch Recalls RayStation and RayPlan Software Due to Treatment Plan Errors

    RaySearch is recalling RayStation and RayPlan software versions due to potential errors in treatment plan reports, including incorrect dose information and couch angles.

    Product
    RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service packs. RayStation 10A and RayPlan 10A are also affected, but not the 10A service pack. (Model No. 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, 9.1, 9.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0478-2021·2020-12-02

    RayStation software recall for potential incorrect treatment plan references

    RaySearch Laboratories is recalling RayStation software because missing data may cause treatment plans to reference incorrect regions or points of interest.

    Product
    RayStation standalone software treatment planning system, Model No. 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, 9.1, 9.2, 10.0 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation propose
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2899-2020·2020-09-02

    RayCare Oncology Software Recalled for Offline Image Review Error

    RaySearch Laboratories AB is recalling RayCare oncology software due to an error message that may prevent users from accessing offline images during review tasks.

    Product
    RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2426-2020·2020-07-01

    RayStation Software Recalled for Treatment Record Import and Display Issues

    RaySearch Laboratories AB is recalling RayStation standalone software due to issues with treatment record imports and gantry angle display.

    Product
    RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2340-2020·2020-06-17

    RayStation 5 Service Pack 3 Radiation Therapy Software Recalled

    RaySearch Laboratories is recalling RayStation 5 Service Pack 3 software due to a dose calculation error that may underestimate radiation dose.

    Product
    RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2348-2020·2020-06-17

    RayStation 8B Software Recall for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation 8B Service Pack 2 software due to a defect in dose calculation algorithms that could underestimate radiation dose.

    Product
    RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2349-2020·2020-06-17

    RayStation 9A Software Recall for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation 9A software due to errors in dose calculation algorithms that could underestimate radiation therapy doses.

    Product
    RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2342-2020·2020-06-17

    RayStation 6 Service Pack 2 Radiation Therapy Software Recalled for Dose Calculation Error

    RaySearch Laboratories is recalling RayStation 6 Service Pack 2 software due to a calculation error that could underestimate radiation dose.

    Product
    RayStation 6 Service Pack 2, UDI # 07350002010075 - 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-2346-2020·2020-06-17

    RayStation 8B Software Recall for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation 8B software due to errors in dose calculation algorithms that could underestimate radiation dose.

    Product
    RayStation 8B, UDI # 07350002010129 - 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-2345-2020·2020-06-17

    RayStation 8A Software Recall for Dose Calculation Error

    RaySearch Laboratories is recalling RayStation 8A Service Pack 1 software due to a dose calculation error that could underestimate radiation therapy doses.

    Product
    RayStation 8A Service Pack 1, UDI # 07350002010136 - 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-2351-2020·2020-06-17

    RayStation 9B Software Recall for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation 9B Service Pack 1 due to a software error in dose calculation algorithms that could result in local underestimation of expected radiation dose.

    Product
    RayStation 9B Service Pack 1, UDI # 07350002010297 - 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-2347-2020·2020-06-17

    RayStation 8B Service Pack 1 Recalled for Dose Calculation Error

    RaySearch Laboratories is recalling RayStation 8B Service Pack 1 due to a software error that could underestimate radiation dose.

    Product
    RayStation 8B Service Pack 1, UDI # 07350002010204 - 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-2350-2020·2020-06-17

    RayStation 9B Software Recalled for Dose Calculation Error

    RaySearch Laboratories is recalling RayStation 9B software due to a dose calculation error that could underestimate radiation therapy doses.

    Product
    RayStation 9B, UDI # 07350002010266 - 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-2344-2020·2020-06-17

    RayStation 8A Radiation Therapy Software Recalled for Dose Calculation Error

    RaySearch Laboratories is recalling RayStation 8A software due to a defect in dose calculation algorithms that may underestimate radiation dose.

    Product
    RayStation 8A, UDI # 07350002010112 - 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-2341-2020·2020-06-17

    RayStation 6 Radiation Therapy Software Recalled for Dose Calculation Error

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

    Product
    RayStation 6, UDI # 07350002010013 - 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-2353-2020·2020-06-17

    RayStation 7 Software Recalled for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation 7 software due to errors in dose calculation algorithms that may underestimate radiation dose.

    Product
    RayStation 7, UDI # 07350002010068 - 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-2339-2020·2020-06-17

    RayStation Radiation Therapy Software Recalled for Dose Calculation Error

    RaySearch Laboratories is recalling RayStation software versions 4.0 to 5.0 Service Pack 2 due to a dose calculation error that may underestimate radiation dose.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide