Recall Record

Stockholm, N/A, Sweden

RAYSEARCH LABORATORIES AB recalls

37 recalls recorded since 2018, most recently on 20 May 2026. 16 are listed as ongoing. Status and classification are as published by the FDA.

Recalls37
Ongoing (FDA)16
Terminated or completed21
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
20 May 2026
Reason
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
Distribution
Worldwide - US Nationwide distribution.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-2646-2026, Z-2647-2026

Ongoing Class II Medical devices

Recall started
28 November 2025
Reason
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
Distribution
Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1110-2026, Z-1106-2026, Z-1108-2026, Z-1109-2026, Z-1104-2026, Z-1105-2026, Z-1103-2026, Z-1107-2026, Z-1102-2026

Ongoing Class II Medical devices

Recall started
8 August 2025
Reason
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Distribution
Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, France, Germany, Hong Kong S.A.R., China, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, ENG, Thailand, Turkey,
Initiated
Voluntary: Firm initiated
Recall numbers
Z-2492-2025, Z-2488-2025, Z-2491-2025, Z-2489-2025, Z-2494-2025, Z-2490-2025, Z-2493-2025, Z-2487-2025, Z-2495-2025

Ongoing Class II Medical devices

Recall started
16 January 2025
Reason
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Belgium ENG, Canada, China, China APactron, Denmark, France, Germany, Hong Kong S.A.R. China, India, Italy, Japan, Korea, Netherlands, Norway, Poland, Singapore, Spain, SwitzerlandENG, Taiwan, Thailand, UK.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1189-2025, Z-1190-2025, Z-1186-2025, Z-1188-2025, Z-1195-2025, Z-1185-2025, Z-1187-2025, Z-1192-2025, Z-1191-2025, Z-1194-2025, Z-1193-2025

Ongoing Class II Medical devices

Recall started
28 March 2024
Reason
Potential for reported SSD to be too high.
Distribution
Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zeal
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1750-2024, Z-1743-2024, Z-1744-2024, Z-1748-2024, Z-1742-2024, Z-1752-2024, Z-1741-2024, Z-1746-2024, Z-1747-2024, Z-1749-2024, Z-1751-2024, Z-1745-2024

Ongoing Class II Medical devices

Recall started
23 February 2024
Reason
A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hong Kong S.A.R., Hungary, India, Indonesia, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand,
Initiated
Voluntary: Firm initiated
Recall number
Z-1482-2024

Ongoing Class II Medical devices

Recall started
12 September 2023
Reason
An issue was found in RayCare 5B, 6A, including service packs, where values will not be visible for documents in a read-only state when opened outside the Documents workspace when using document fields configured with single- or multi-selectable values.
Distribution
MD, TN
Initiated
Voluntary: Firm initiated
Recall number
Z-0206-2024

Ongoing Class II Medical devices

Recall started
17 July 2023
Reason
An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be displayed as expected under certain circumstances
Distribution
US Nationwide distribution in the state of TN.
Initiated
Voluntary: Firm initiated
Recall number
Z-2464-2023

Ongoing Class II Medical devices

Recall started
17 February 2023
Reason
It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the VSIM Export button, the angle will not be correct in the exported RT plan. In the exported RT plan, the DICOM attribute Beam Limiting Device Angle (300A,0120) is set to zero, regardless of the selected collimator angle.
Distribution
US Nationwide
Initiated
Voluntary: Firm initiated
Recall number
Z-1281-2023

Terminated Class II Medical devices

Recall started
10 June 2022
Terminated
11 June 2024
Reason
This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might be misleading. Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam.
Distribution
US Nationwide distribution in the states of NJ and TX.
Initiated
Voluntary: Firm initiated
Recall number
Z-1299-2022

Terminated Class II Medical devices

Recall started
1 June 2022
Terminated
4 October 2023
Reason
An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.
Distribution
Worldwide distribution - US Nationwide distribution in the state of TN and the countries of Belgium and Switzerland.
Initiated
Voluntary: Firm initiated
Recall number
Z-1403-2022

Ongoing Class II Medical devices

Recall started
30 December 2021
Reason
If a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary and secondary image set in all side-by-side views. This will also be true for any new patient or case opened while the cine loop is running
Distribution
US Nationwide distribution.
Initiated
Voluntary: Firm initiated
Recall number
Z-0732-2022

Ongoing Class II Medical devices

Recall started
22 September 2021
Reason
An issue where the combined density in a dose grid voxel partially covered by the External ROI and also partially covered by an ROI of type Bolus, Support or Fixation may be unexpected.The density in the voxel can be both under- and overestimated
Distribution
US Nationwide.
Initiated
Voluntary: Firm initiated
Recall number
Z-0849-2022

Terminated Class II Medical devices

Recall started
9 September 2021
Terminated
16 April 2024
Reason
If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the target ROI, the positions of the jaws may change unexpectedly for some control points. User must be aware to avoid unnecessary jaw openings during treatment planning
Distribution
US Nationwide distribution in the states of AL, CA, FL, GA, IA, IL, MO, MS, NC, OK, OR, SC, TN, WA, WI.
Initiated
Voluntary: Firm initiated
Recall number
Z-0848-2022

Terminated Class II Medical devices

Recall started
8 June 2021
Terminated
20 March 2024
Reason
Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.
Distribution
US distribution to TN; and Belgium
Initiated
Voluntary: Firm initiated
Recall number
Z-2138-2021

Terminated Class II Medical devices

Recall started
21 April 2021
Terminated
27 July 2023
Reason
Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after editing the clinical goal. It also describes an issue with contouring when the spacing between slices is d 1 mm, present in RayStation/RayPlan versions from 6 up to 10A.
Distribution
Worldwide distribution - US Nationwide distribution in the states of AK, AL, AZ, CA, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, Colombia
Initiated
Voluntary: Firm initiated
Recall number
Z-1838-2021

Terminated Class II Medical devices

Recall started
7 April 2021
Terminated
2 June 2023
Reason
When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose tracking and the fractions that are included in the dose summation. The issue only affects RayTreat users and only the Total dose option. Accumulation and other options in Dose tracking are correct.
Distribution
Domestic: TN
Initiated
Voluntary: Firm initiated
Recall number
Z-1598-2021

Ongoing Class II Medical devices

Recall started
25 March 2021
Reason
Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.
Distribution
US Nationwide in the state of TN.
Initiated
Voluntary: Firm initiated
Recall number
Z-1427-2021

Ongoing Class II Medical devices

Recall started
3 March 2021
Reason
Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later
Distribution
US Nationwide distribution in the state of TN.
Initiated
Voluntary: Firm initiated
Recall number
Z-1281-2021

Terminated Class II Medical devices

Recall started
22 February 2021
Terminated
1 May 2023
Reason
For some LINAC types, merging clinical beams with beams of approximate dose may lead to the approximate dose erroneously labeled as clinical dose. Merge beams can be used manually, in scripting, or as part of the Automated breast planning feature. In some cases, when merging two beams where the first beam has clinical dose and the second beam has approximate dose, the dose of the resulting beam will be labeled as Clinical, although dose for some of the beam segments is still calculated with the SVD dose engine and it should be labeled Approximate: Mixed dose. The difference between approximate and final Clinical dose is in most cases small, but there can be body sites such as lung where the difference can be significant.
Distribution
US Nationwide distribution.
Initiated
Voluntary: Firm initiated
Recall number
Z-1597-2021

Terminated Class II Medical devices

Recall started
11 November 2020
Terminated
9 May 2023
Reason
Two issues were found with the treatment plan report: 1) There may be incorrect information for the percent of a region of interest with a clinical goal that is outside the dose grid; and 2) For RayStation and RayPlan 9B and 10A, 6D couch angles may be incorrect.
Distribution
US Nationwide distribution.
Initiated
Voluntary: Firm initiated
Recall number
Z-0589-2021

Terminated Class II Medical devices

Recall started
8 October 2020
Terminated
30 March 2023
Reason
If a region of interest (ROI) or point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure Set, the reference may become linked to the wrong ROI or POI.
Distribution
US Nationwide distribution.
Initiated
Voluntary: Firm initiated
Recall number
Z-0478-2021

Ongoing Class II Medical devices

Recall started
29 July 2020
Reason
When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the treatment image related to the fraction and the planning image selected. When starting the task, an error message might be displayed stating: Review files not available.
Distribution
US Nationwide distribution including in the state of Tennessee.
Initiated
Voluntary: Firm initiated
Recall number
Z-2899-2020

Ongoing Class II Medical devices

Recall started
26 May 2020
Reason
It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the display of planned and recorded Gantry Angle in the delivered beam list in RayTreat.
Distribution
Distributed to one consignee in Nashville. Foreign distribution to one consignee in Belgium.
Initiated
Voluntary: Firm initiated
Recall number
Z-2426-2020

Terminated Class II Medical devices

Recall started
18 May 2020
Terminated
6 August 2021
Reason
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Distribution
US Nationwide distribution including in the states of Florida, Georgia, Utah, Virginia, California, Maryland, Arizona, Texas, Washington DC, Missouri, Massachusetts, Illinois, Oklahoma, New Jersey, Tennessee, and Louisiana.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-2342-2020, Z-2345-2020, Z-2340-2020, Z-2343-2020, Z-2349-2020, Z-2346-2020, Z-2351-2020, Z-2344-2020, Z-2353-2020, Z-2348-2020, Z-2339-2020, Z-2341-2020 and 3 more

Ongoing Class II Medical devices

Recall started
4 March 2020
Reason
Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtual Wedge fields recommended by the LINAC vendor will be more restricted in the wedged direction than the maximum field opening without a wedge. Delivering a larger field opening with a virtual wedge will not result in a wedged field shape over the entire field. Instead, a high dose plateau region will be the result at the toe side of the field beyond the recommended field size.
Distribution
US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, and WI.
Initiated
Voluntary: Firm initiated
Recall number
Z-1598-2020

Terminated Class II Medical devices

Recall started
20 February 2020
Terminated
5 November 2024
Reason
There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
Distribution
The products were distributed to the following US states: TN
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1466-2020, Z-1463-2020, Z-1465-2020, Z-1468-2020, Z-1464-2020, Z-1462-2020, Z-1467-2020

Terminated Class II Medical devices

Recall started
19 December 2019
Terminated
24 November 2020
Reason
Three issues found: i) The Map ROI options in the ROI list in the Structure Definition module may generate unintended ROI geometries ii) Elekta guard leaf behavior. There is an interoperability issue with Elekta regarding setting of guard leaves. iii)SSD, when intended as source-to-surface distance, it sometimes gives source-to-skin distance.To the best of our knowledge, these issues have not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect dose calculations during treatment planning.
Distribution
US Nationwide distribution in states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, WI
Initiated
Voluntary: Firm initiated
Recall number
Z-0866-2020

Terminated Class II Medical devices

Recall started
18 November 2019
Terminated
10 November 2020
Reason
Editing a static arc beam may unexpectedly set the MU of the beam to its initial default value of 200 MU. If the bug is triggered, the dose is invalidated and needs to be recalculated before the plan can be approved or exported.
Distribution
US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, and WI.
Initiated
Voluntary: Firm initiated
Recall number
Z-0736-2020

Terminated Class II Medical devices

Recall started
12 November 2018
Terminated
17 April 2020
Reason
Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A. In these versions, isocenter shifts in dose tracking are incorrectly interpreted according to the DICOM patient coordinate system.
Distribution
AZ CA CO CT DE FL GA HI ID IL LA MA MD ME MI MO MS NC NJ NY OH OR PA RI TN TX VA VT WA WI
Initiated
Voluntary: Firm initiated
Recall number
Z-0679-2019

Terminated Class II Medical devices

Recall started
21 September 2018
Terminated
16 June 2020
Reason
Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7.
Distribution
Nationwide
Initiated
Voluntary: Firm initiated
Recall number
Z-0294-2019

Terminated Class II Medical devices

Recall started
29 June 2018
Terminated
16 July 2020
Reason
If the beam model has a highly asymmetric primary source, it is not correctly taken into account in the calculation of DMLC fields when the collimator is rotated. This could lead to potentially significant overdosage at delivery. The user must be aware of the issue to avoid incorrect dose calculations during treatment planning.
Distribution
US Nationwide Distribution to accounts in AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, and WI.
Initiated
Voluntary: Firm initiated
Recall number
Z-2497-2018

Terminated Class II Medical devices

Recall started
6 June 2018
Terminated
4 April 2019
Reason
The firm has learned that some RayStation/RayPlan users have commissioned machines with erroneous Beam profile correction parameters. These parameters affect the dose calculated in corners of large or off-axis fields. This effect cannot be seen in the Beam Commissioning module and dose in large or off-axis fields needs to be validated using the Beam 3D Modeling module in RayPhysics/RayPlan Physics. The user must be aware to avoid incorrect dose calculations during treatment planning.
Distribution
US Nationwide distribution.
Initiated
Voluntary: Firm initiated
Recall number
Z-2554-2018

Terminated Class II Medical devices

Recall started
28 March 2018
Terminated
27 May 2020
Reason
The dose calculation accuracy may in some situations be less than expected. The user must be aware in order to avoid incorrect dose calculations during treatment planning.
Distribution
US Nationwide Distribution in the states of AL, AR, AZ, CA, CT, DC, DE, FL, GA, HI, ID, IL, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, VT, WA, WI.
Initiated
Voluntary: Firm initiated
Recall number
Z-2290-2018

Terminated Class II Medical devices

Recall started
26 January 2018
Terminated
13 January 2020
Reason
Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient.
Distribution
Nationwide
Initiated
Voluntary: Firm initiated
Recall number
Z-1275-2018

Terminated Class II Medical devices

Recall started
20 November 2017
Terminated
8 August 2023
Reason
When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong
Distribution
US Nationwide Distribution
Initiated
Voluntary: Firm initiated
Recall number
Z-1930-2019

Terminated Class II Medical devices

Recall started
17 July 2017
Terminated
29 August 2018
Reason
For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used for QA measurements. This could result in an incorrect dosage being provided to a patient.
Distribution
US Nationwide Distribution - FL, WA, AZ, TN, MD, TX, FL, MI, Washington D.C.
Initiated
Voluntary: Firm initiated
Recall number
Z-0380-2018

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.