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.

101–115 of 115

HighFDA (Devices)·Z-2206-2016·2016-07-27
RayStation Radiation Therapy Software Recalled for Incorrect Biological Goal Evaluation
RaySearch Laboratories is recalling RayStation radiation therapy software versions 3.0 through 5 due to incorrect biological clinical goal values for adapted plans.
Product
RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy Treatment Planning System --- designed for treatment planning and analysis of radiation therapy, provides treatment unit set up parameters and estimates dose dist
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-1712-2016·2016-06-01
RayStation Therapy Treatment Planning Software Recalled for Synchronization Bug
RaySearch Laboratories is recalling RayStation Therapy Treatment Planning System software due to a bug that can cause views to become unsynchronized with stored data.
Product
RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy.
Category
Medical Device
Distribution
24 states
ModerateFDA (Devices)·Z-2785-2015·2015-09-23
RayStation Radiation Therapy Software Recalled for Display Errors
RaySearch Laboratories is recalling RayStation software due to a floating-point precision error that affects the display of isodose lines and color tables.
Product
Radiation Therapy Treatment Planning System software 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 proposed
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2457-2015·2015-09-02
RayStation 4.7.1 Radiation Therapy Software Recalled for Algorithm Error
RaySearch Laboratories is recalling RayStation 4.7.1 software due to an algorithm error that reverses contraction distances in radiation therapy planning.
Product
RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1679-2015·2015-06-03
RaySearch RayStation Software Recalled for Dose Calculation Errors
RaySearch Laboratories AB is recalling RayStation software versions 2.5 through 4.0 due to dose calculation issues in specific VMAT plans.
Product
RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment 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 distri
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1310-2015·2015-04-01
RayStation Radiation Therapy Software Recalled for Dose Calculation Errors
RaySearch Laboratories is recalling RayStation Radiation Therapy Treatment Planning System software due to an issue with photon dose calculation for Dynamic MLC plans.
Product
RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for t
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1806-2014·2014-06-25
RayStation Software Recall for Radiation Therapy Dose Calculation Errors
RaySearch Laboratories is recalling RayStation software version 4.0.3.4 due to a bug that causes incorrect dose calculations for radiation therapy plans with variable CT slice spacing.
Product
RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1481-2014·2014-04-30
RaySearch Ray Station Software Recalled for Dose Miscalculations
RaySearch Laboratories is recalling Ray Station software versions 2.0 through 4.0 due to dose miscalculations for support structures on CT images.
Product
RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1308-2014·2014-04-09
RaySearch Ray Station 4.0 software recalled for dose calculation errors
RaySearch Laboratories is recalling Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.
Product
RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1307-2014·2014-04-09
RayStation Radiation Therapy Software Recalled for Potential Dose Errors
RaySearch Laboratories is recalling RayStation Radiation Therapy Treatment Planning System software due to potential dose errors caused by program errors.
Product
RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-0281-2014·2013-11-20
Ray Station Radiation Therapy System Recalled for Dose Calculation Error
Ray Search Laboratories is recalling Ray Station 3.0, 3.5, and 4.0 systems due to a dose calculation error involving Elekta motorized wedges.
Product
Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-1419-2013·2013-06-05
RayStation Therapy Treatment Planning System Recalled for Image Offset Errors
RaySearch Laboratories AB is recalling RayStation Therapy Treatment Planning System software versions 2.0, 2.5, and 3.0 because imported medical images may be offset by one pixel, potentially leading to incorrect dose calculations.
Product
RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2444-2012·2012-10-03
RaySearch SharePlan Software Recalled for Unexpected Import Behavior
RaySearch Laboratories is recalling SharePlan 1.1 software due to unexpected behavior when importing specific files. The issue has not caused patient mistreatment.
Product
SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-2378-2012·2012-09-26
RaySearch TomoTherapy SharePlan Software Field Notice for Unexpected Behaviors
RaySearch Laboratories issued a field notice for TomoTherapy SharePlan software due to two unexpected behaviors not clearly described in the user manual. No patient mistreatment or incidents have occurred.
Product
The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10. Intended use: t-
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-2324-2012·2012-09-12
RayStation Treatment Planning Software Recalled for Dose Calculation Error
RaySearch Laboratories AB is recalling RayStation software versions 2.5.0.144 and 2.5.1.89 due to a dose calculation normalization issue. No patient mistreatment has occurred.
Product
Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment pla
Category
Medical Device
Distribution
Distributed nationwide