RayStation Radiation Therapy Planning Software Recalled for Data Unique ID Issue

Agency Publication Date: September 2, 2025

Summary

RaySearch Laboratories AB is recalling approximately 103 units of RayStation Radiation Therapy Treatment Planning System software. The recall covers multiple software versions ranging from version 6 to version 15. The system contains a defect where unique identifiers for medical data sequences are not guaranteed to be unique when using the interface for Accuray's iDMS system. This could potentially lead to data errors or mismatches during radiation treatment planning.

Risk

The lack of unique data identifiers could cause medical images or treatment sequences to be incorrectly identified or overwritten. This poses a risk of clinicians using incorrect data to plan or deliver radiation therapy to patients.

What You Should Do

This recall affects RaySearch RayStation Radiation Therapy Treatment Planning System software versions 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15, including various Service Packs.
Check the software version and Unique Device Identifier (UDI) currently installed on your planning systems. See the Affected Products section below for the full list of affected codes.
Stop using the recalled software versions for patient treatment planning if they interface with Accuray's iDMS until a correction has been implemented.
Contact RaySearch Laboratories AB or your local distributor to arrange for a software update or technical correction.
Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: RayStation Radiation Therapy Treatment Planning System (Versions 7, 8A)

Variants: Version 7.0.0.19, Version 8.0.0.61, Version 8.0.1.10 (Service Pack 1)

Model / REF:

RayStation 7

RayStation 8A

Lot Numbers:

Expiration Date: 2023-10-04

UDI:

0735000201006820171130

0735000201011220180608

0735000201013620180928

Recall #: Z-2487-2025

Product: RayStation Radiation Therapy Treatment Planning System (Versions 8B, 9A)

Variants: Version 8.1.0.47, Version 8.1.1.8 (Service Pack 1), Version 8.1.2.5 (Service Pack 2), Version 9.0.0.113, Version 9.0.1.142 (Service Pack 1)

Model / REF:

RayStation 8B

RayStation 9A

Lot Numbers:

Expiration Date: 2027-12-15

UDI:

0735000201012920181209

0735000201020420190214

0735000201023520190524

0735000201017420190612

0735000201048820220420

Recall #: Z-2488-2025

Product: RayStation Radiation Therapy Treatment Planning System (Versions 9B, 10A)

Variants: Version 9.1.0.933, Version 9.2.0.483 (Service Pack 1), Version 10.0.0.1154, Version 10.0.1.52 (Service Pack 1), Version 10.0.2.10 (Service Pack 2)

Model / REF:

RayStation 9B

RayStation 10A

Lot Numbers:

Expiration Date: 2025-06-16

UDI:

0735000201026620191220

0735000201029720200310

0735000201030320200526

0735000201036520200526

0735000201065520220608

Recall #: Z-2489-2025

Product: RayStation Radiation Therapy Treatment Planning System (Version 10B)

Variants: Version 10.1.0.613, Version 10.1.1.54 (Service Pack 1)

Model / REF:

RayStation 10B

Lot Numbers:

Expiration Date: 2027-02-01

UDI:

0735000201031020201216

0735000201047120220128

Recall #: Z-2490-2025

Product: RayStation Radiation Therapy Treatment Planning System (Version 11A)

Variants: Version 11.0.0.951, Version 11.0.1.29 (Service Pack 1), Version 11.0.3.116 (Service Pack 2), Version 11.0.4.15 (Service Pack 3)

Model / REF:

RayStation 11A

Lot Numbers:

Expiration Date: 2027-06-22

UDI:

0735000201038920210518

0735000201043320210610

0735000201044020210916

0735000201063120220616

Recall #: Z-2491-2025

Product: RayStation Radiation Therapy Treatment Planning System (Version 11B)

Variants: Version 12.0.0.932, Version 12.1.0.1221 (Service Pack 1), Version 12.0.3.68 (Service Pack 2), Version 12.0.4.12 (Service Pack 3), Version 12.3.0.119 (Service Pack Toshiba 1)

Model / REF:

RayStation 11B

Lot Numbers:

Expiration Date: 2028-03-20

UDI:

0735000201042620211208

0735000201049520220312

0735000201050120220422

0735000201060020220620

0735000201057020221222

Recall #: Z-2492-2025

Product: RayStation Radiation Therapy Treatment Planning System (Version 12A)

Variants: Version 13.0.0.1547, Version 13.1.0.144 (Service Pack 1), Version 13.1.1.89 (Service Pack 2)

Model / REF:

RayStation 12A

Lot Numbers:

Expiration Date: 2028-07-07

UDI:

0735000201054920220616

0735000201067920221007

0735000201073020230913

Recall #: Z-2493-2025

Product: RayStation Radiation Therapy Treatment Planning System (Version 6)

Variants: Version 6.1.1.2 (Service Pack 1), Version 6.2.0.7 (Service Pack 2), Version 6.3.0.6 (Service Pack 3)

Model / REF:

RayStation 6

Lot Numbers:

Expiration Date: 2024-10-18

UDI:

0735000201008220170529

0735000201007520170630

0735000201024220190923

Recall #: Z-2494-2025

Product: RayStation Radiation Therapy Treatment Planning System (Versions 2023B, 2024A)

Variants: Version 14.0.0.3338, Version 15.0.0.430, Version 15.1.3.10 (2024A SP3)

Model / REF:

RayStation 2023B

RayStation 2024A

Lot Numbers:

Expiration Date: 2030-02-21

UDI:

0735000201055620230630

0735000201072320231213

0735000201087720241106

Recall #: Z-2495-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97400

Status: Active

Manufacturer: RAYSEARCH LABORATORIES AB

Sold By: Authorized distributors; Direct medical software sales

Manufactured In: Sweden

Units Affected: 9 products (1; 2; 26; 3; 3; 6; 13; 0; 49)

Distributed To: Alabama, California, Florida, Georgia, Illinois, Iowa, Kentucky, Louisiana, Maryland, Minnesota, Mississippi, New York, North Carolina, Ohio, Oklahoma, South Carolina, Washington, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects RaySearch RayStation Radiation Therapy Treatment Planning System software versions 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15, including various Service Packs.

Check the software version and Unique Device Identifier (UDI) currently installed on your planning systems. See the Affected Products section below for the full list of affected codes.

Stop using the recalled software versions for patient treatment planning if they interface with Accuray's iDMS until a correction has been implemented.

Contact RaySearch Laboratories AB or your local distributor to arrange for a software update or technical correction.

Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this recall.

Affected Products

Product: RayStation Radiation Therapy Treatment Planning System (Versions 7, 8A)

Variants: Version 7.0.0.19, Version 8.0.0.61, Version 8.0.1.10 (Service Pack 1)

Model / REF:

RayStation 7

RayStation 8A

Lot Numbers:

Expiration Date: 2023-10-04

UDI:

0735000201006820171130

0735000201011220180608

0735000201013620180928

Recall #: Z-2487-2025

Product: RayStation Radiation Therapy Treatment Planning System (Versions 8B, 9A)

Variants: Version 8.1.0.47, Version 8.1.1.8 (Service Pack 1), Version 8.1.2.5 (Service Pack 2), Version 9.0.0.113, Version 9.0.1.142 (Service Pack 1)

Model / REF:

RayStation 8B

RayStation 9A

Lot Numbers:

Expiration Date: 2027-12-15

UDI:

0735000201012920181209

0735000201020420190214

0735000201023520190524

0735000201017420190612

0735000201048820220420

Recall #: Z-2488-2025

Product: RayStation Radiation Therapy Treatment Planning System (Versions 9B, 10A)

Variants: Version 9.1.0.933, Version 9.2.0.483 (Service Pack 1), Version 10.0.0.1154, Version 10.0.1.52 (Service Pack 1), Version 10.0.2.10 (Service Pack 2)

Model / REF:

RayStation 9B

RayStation 10A

Lot Numbers:

Expiration Date: 2025-06-16

UDI:

0735000201026620191220

0735000201029720200310

0735000201030320200526

0735000201036520200526

0735000201065520220608

Recall #: Z-2489-2025

Product: RayStation Radiation Therapy Treatment Planning System (Version 10B)

Variants: Version 10.1.0.613, Version 10.1.1.54 (Service Pack 1)

Model / REF:

RayStation 10B

Lot Numbers:

Expiration Date: 2027-02-01

UDI:

0735000201031020201216

0735000201047120220128

Recall #: Z-2490-2025

Product: RayStation Radiation Therapy Treatment Planning System (Version 11A)

Variants: Version 11.0.0.951, Version 11.0.1.29 (Service Pack 1), Version 11.0.3.116 (Service Pack 2), Version 11.0.4.15 (Service Pack 3)

Model / REF:

RayStation 11A

Lot Numbers:

Expiration Date: 2027-06-22

UDI:

0735000201038920210518

0735000201043320210610

0735000201044020210916

0735000201063120220616

Recall #: Z-2491-2025

Product: RayStation Radiation Therapy Treatment Planning System (Version 11B)

Variants: Version 12.0.0.932, Version 12.1.0.1221 (Service Pack 1), Version 12.0.3.68 (Service Pack 2), Version 12.0.4.12 (Service Pack 3), Version 12.3.0.119 (Service Pack Toshiba 1)

Model / REF:

RayStation 11B

Lot Numbers:

Expiration Date: 2028-03-20

UDI:

0735000201042620211208

0735000201049520220312

0735000201050120220422

0735000201060020220620

0735000201057020221222

Recall #: Z-2492-2025

Product: RayStation Radiation Therapy Treatment Planning System (Version 12A)

Variants: Version 13.0.0.1547, Version 13.1.0.144 (Service Pack 1), Version 13.1.1.89 (Service Pack 2)

Model / REF:

RayStation 12A

Lot Numbers:

Expiration Date: 2028-07-07

UDI:

0735000201054920220616

0735000201067920221007

0735000201073020230913

Recall #: Z-2493-2025

Product: RayStation Radiation Therapy Treatment Planning System (Version 6)

Variants: Version 6.1.1.2 (Service Pack 1), Version 6.2.0.7 (Service Pack 2), Version 6.3.0.6 (Service Pack 3)

Model / REF:

RayStation 6

Lot Numbers:

Expiration Date: 2024-10-18

UDI:

0735000201008220170529

0735000201007520170630

0735000201024220190923

Recall #: Z-2494-2025

Product: RayStation Radiation Therapy Treatment Planning System (Versions 2023B, 2024A)

Variants: Version 14.0.0.3338, Version 15.0.0.430, Version 15.1.3.10 (2024A SP3)

Model / REF:

RayStation 2023B

RayStation 2024A

Lot Numbers:

Expiration Date: 2030-02-21

UDI:

0735000201055620230630

0735000201072320231213

0735000201087720241106

Recall #: Z-2495-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97400

Status: Active

Manufacturer: RAYSEARCH LABORATORIES AB

Sold By: Authorized distributors; Direct medical software sales

Manufactured In: Sweden

Units Affected: 9 products (1; 2; 26; 3; 3; 6; 13; 0; 49)