RayStation Radiation Therapy Software Recalled for Incorrect Dose Calculations

Agency Publication Date: February 19, 2025

Summary

RaySearch Laboratories AB is recalling 46 units of its RayStation Radiation Therapy Treatment Planning System software across versions 4.5 through 2024B. The recall was initiated due to an inconsistency in how the software calculates radiation doses for certain proton and light ion treatment plans, specifically when using a particular CT calibration curve. This defect could cause patients to receive radiation doses that differ from what was intended by their healthcare team. No incidents or injuries have been reported to date. This system is distributed through authorized medical device distributors and direct sales.

Risk

The software may produce inconsistent dose calculations during treatment planning, which could lead to patients receiving incorrect radiation doses. This poses a risk of treatment being less effective than planned or causing unintended damage to healthy tissue.

What You Should Do

The recalled product is the RayStation Radiation Therapy Treatment Planning System software, affecting versions 4.5 through 2024B, including various service packs.
Check the software version and serial number of your RayStation system to identify if it is affected; identifiers include software revisions such as RayStation 4.5 through 12A and serial numbers such as 7.0.0.19, 10.1.0.613, and 14.0.0.3338. See the Affected Products section below for the full list of affected codes.
Stop using the recalled product for affected treatment types. Contact RaySearch Laboratories AB or your authorized distributor to arrange for a software update, correction, or replacement.
Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for more information regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled product for affected treatment plans. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: RayStation Radiation Therapy Treatment Planning System

Variants: RayStation 7, RayStation 8A, RayStation 8A Service Pack 1

Model / REF:

7.0.0.19

8.0.0.61

8.0.1.10

Serial Numbers:

7.0.0.19

8.0.0.61

8.0.1.10

UDI:

0735000201006820171130

0735000201011220180608

0735000201013620180928

GTIN:

07350002010068

07350002010112

07350002010136

Date Ranges: Expiration Date: 2023-10-04

Recall number Z-1185-2025

Product: RayStation Radiation Therapy Treatment Planning System

Variants: RayStation 8B, RayStation 8B Service Pack 1, RayStation 8B Service Pack 2, RayStation 9A, RayStation 9A Service Pack 1

Model / REF:

8.1.0.47

8.1.1.8

8.1.2.5

9.0.0.113

9.0.1.142

Serial Numbers:

8.0.0.61

8.0.1.10

9.0.0.113

9.0.1.142

UDI:

0735000201011220180608

0735000201013620180928

0735000201017420190612

0735000201048820220420

GTIN:

07350002010112

07350002010136

07350002010174

07350002010488

Date Ranges: Expiration Date: 2027-12-15

Recall number Z-1186-2025

Product: RayStation Radiation Therapy Treatment Planning System

Variants: RayStation 9B, RayStation 9B Service Pack 1, RayStation 10A, RayStation 10A Service Pack 1, RayStation 10A Service Pack 2

Model / REF:

9.1.0.933

9.2.0.483

10.0.0.1154

10.0.1.52

10.0.2.10

Serial Numbers:

9.1.0.933

9.2.0.483

10.0.0.1154

10.0.1.52

10.0.2.10

UDI:

0735000201026620191220

0735000201029720200310

0735000201030320200526

0735000201036520200526

0735000201065520220608

GTIN:

07350002010266

07350002010297

07350002010303

07350002010365

07350002010655

Date Ranges: Expiration Date: 2025-06-16

Recall number Z-1187-2025

Product: RayStation Radiation Therapy Treatment Planning System

Variants: RayStation 10B, RayStation 10B Service Pack 1

Model / REF:

10.1.0.613

10.1.1.54

Serial Numbers:

10.1.0.613

10.1.1.54

UDI:

0735000201031020201216

0735000201047120220128

GTIN:

07350002010310

07350002010471

Date Ranges: Expiration Date: 2027-02-01

Recall number Z-1188-2025

Product: RayStation Radiation Therapy Treatment Planning System

Variants: RayStation 11A, RayStation 11A Service Pack 1, RayStation 11A Service Pack 2, RayStation 11A Service Pack 3

Model / REF:

11.0.0.951

11.0.1.29

11.0.3.116

11.0.4.15

Serial Numbers:

11.0.0.951

11.0.1.29

11.0.3.116

11.0.4.15

UDI:

0735000201038920210518

0735000201043320210610

0735000201044020210916

0735000201063120220616

GTIN:

07350002010389

07350002010433

07350002010440

07350002010631

Date Ranges: Expiration Date: 2027-06-22

Recall number Z-1189-2025

Product: RayStation Radiation Therapy Treatment Planning System

Variants: RayStation 11B, RayStation 11B Service Pack 1, RayStation 11B Service Pack 2, RayStation 11B Service Pack 3, Service Pack Toshiba 1

Model / REF:

12.0.0.932

12.1.0.1221

12.0.3.68

12.0.4.12

12.3.0.119

Serial Numbers:

12.0.0.932

12.1.0.1221

12.0.3.68

12.0.4.12

12.3.0.119

UDI:

0735000201042620211208

0735000201049520220312

0735000201050120220422

0735000201060020220620

0735000201057020221222

GTIN:

07350002010426

07350002010495

07350002010501

07350002010600

07350002010570

Date Ranges: Expiration Date: 2028-03-20

Recall number Z-1190-2025

Product: RayStation Radiation Therapy Treatment Planning System

Variants: RayStation 12A, RayStation 12A Service Pack 1, RayStation 12A Service Pack 2, RayStation 2023B

Model / REF:

13.0.0.1547

13.1.0.144

13.1.1.89

14.0.0.3338

Serial Numbers:

13.0.0.1547

13.1.0.144

13.1.1.89

14.0.0.3338

UDI:

0735000201054920220616

0735000201067920221007

0735000201073020230913

0735000201055620230630

GTIN:

07350002010549

07350002010679

07350002010730

07350002010556

Date Ranges: Expiration Date: 2028-07-07

Recall number Z-1191-2025

Product: RayStation Radiation Therapy Treatment Planning System

Variants: RayStation 6 Service Pack 1, RayStation 6 Service Pack 2, RayStation 6 Service Pack 3

Model / REF:

6.1.1.2

6.2.0.7

6.3.0.6

Serial Numbers:

6.1.1.2

6.2.0.7

6.3.0.6

UDI:

0735000201008220170529

0735000201007520170630

0735000201024220190923

GTIN:

07350002010082

07350002010075

07350002010242

Date Ranges: Expiration Date: 2024-10-18

Recall number Z-1192-2025

Product: RayStation Radiation Therapy Treatment Planning System

Variants: RayStation 6

Model / REF:

6.0.0.24

Serial Numbers:

6.0.0.24

UDI:

00735000201001320161214

GTIN:

07350002010013

Date Ranges: Expiration Date: 2021-12-22

Recall number Z-1193-2025

Product: RayStation Radiation Therapy Treatment Planning System

Variants: RayStation 5 Service Pack 2, RayStation 5 Service Pack 3

Model / REF:

5.0.2.35

5.0.3.17

Serial Numbers:

5.0.2.35

5.0.3.17

UDI:

0735000201002020170502

GTIN:

07350002010020

Date Ranges: Expiration Date: 2028-12-21

Recall number Z-1194-2025

Product: RayStation Radiation Therapy Treatment Planning System

Variants: RayStation 4.5.1, RayStation 4.7.2, RayStation 4.7.3, RayStation 4.7.4, RayStation 4.7.5, RayStation 4.7.6

Model / REF:

4.5.1.14

4.7.2.5

4.7.3.13

4.7.4.4

4.7.5.4

4.7.6.7

Serial Numbers:

4.5.1.14

4.7.2.5

4.7.3.13

4.7.4.4

4.7.5.4

4.7.6.7

Date Ranges: Expiration Date: 2025-03-17

Recall number Z-1195-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96156

Status: Active

Manufacturer: RAYSEARCH LABORATORIES AB

Sold By: Authorized Medical Device Distributors; Direct Sales from RaySearch Laboratories

Manufactured In: Sweden

Units Affected: 11 products (0; 1; 1; 0; 6; 5; 32; 1; 0; 0; 0)

Distributed To: Nationwide

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

The recalled product is the RayStation Radiation Therapy Treatment Planning System software, affecting versions 4.5 through 2024B, including various service packs.

Check the software version and serial number of your RayStation system to identify if it is affected; identifiers include software revisions such as RayStation 4.5 through 12A and serial numbers such as 7.0.0.19, 10.1.0.613, and 14.0.0.3338. See the Affected Products section below for the full list of affected codes.

Stop using the recalled product for affected treatment types. Contact RaySearch Laboratories AB or your authorized distributor to arrange for a software update, correction, or replacement.

Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for more information regarding this recall.

Affected Products

Product: RayStation Radiation Therapy Treatment Planning System

Variants: RayStation 7, RayStation 8A, RayStation 8A Service Pack 1

Model / REF:

7.0.0.19

8.0.0.61

8.0.1.10

Serial Numbers:

7.0.0.19

8.0.0.61

8.0.1.10

UDI:

0735000201006820171130

0735000201011220180608

0735000201013620180928

GTIN:

07350002010068

07350002010112

07350002010136

Date Ranges: Expiration Date: 2023-10-04

Recall number Z-1185-2025

Product: RayStation Radiation Therapy Treatment Planning System

Variants: RayStation 8B, RayStation 8B Service Pack 1, RayStation 8B Service Pack 2, RayStation 9A, RayStation 9A Service Pack 1

Model / REF:

8.1.0.47

8.1.1.8

8.1.2.5

9.0.0.113

9.0.1.142

Serial Numbers:

8.0.0.61

8.0.1.10

9.0.0.113

9.0.1.142

UDI:

0735000201011220180608

0735000201013620180928

0735000201017420190612

0735000201048820220420

GTIN:

07350002010112

07350002010136

07350002010174

07350002010488

Date Ranges: Expiration Date: 2027-12-15

Recall number Z-1186-2025

Product: RayStation Radiation Therapy Treatment Planning System

Variants: RayStation 9B, RayStation 9B Service Pack 1, RayStation 10A, RayStation 10A Service Pack 1, RayStation 10A Service Pack 2

Model / REF:

9.1.0.933

9.2.0.483

10.0.0.1154

10.0.1.52

10.0.2.10

Serial Numbers:

9.1.0.933

9.2.0.483

10.0.0.1154

10.0.1.52

10.0.2.10

UDI:

0735000201026620191220

0735000201029720200310

0735000201030320200526

0735000201036520200526

0735000201065520220608

GTIN:

07350002010266

07350002010297

07350002010303

07350002010365

07350002010655

Date Ranges: Expiration Date: 2025-06-16

Recall number Z-1187-2025

Product: RayStation Radiation Therapy Treatment Planning System

Variants: RayStation 10B, RayStation 10B Service Pack 1

Model / REF:

10.1.0.613

10.1.1.54

Serial Numbers:

10.1.0.613

10.1.1.54

UDI:

0735000201031020201216

0735000201047120220128

GTIN:

07350002010310

07350002010471

Date Ranges: Expiration Date: 2027-02-01

Recall number Z-1188-2025

Product: RayStation Radiation Therapy Treatment Planning System

Variants: RayStation 11A, RayStation 11A Service Pack 1, RayStation 11A Service Pack 2, RayStation 11A Service Pack 3

Model / REF:

11.0.0.951

11.0.1.29

11.0.3.116

11.0.4.15

Serial Numbers:

11.0.0.951

11.0.1.29

11.0.3.116

11.0.4.15

UDI:

0735000201038920210518

0735000201043320210610

0735000201044020210916

0735000201063120220616

GTIN:

07350002010389

07350002010433

07350002010440

07350002010631

Date Ranges: Expiration Date: 2027-06-22

Recall number Z-1189-2025

Product: RayStation Radiation Therapy Treatment Planning System

Variants: RayStation 11B, RayStation 11B Service Pack 1, RayStation 11B Service Pack 2, RayStation 11B Service Pack 3, Service Pack Toshiba 1

Model / REF:

12.0.0.932

12.1.0.1221

12.0.3.68

12.0.4.12

12.3.0.119

Serial Numbers:

12.0.0.932

12.1.0.1221

12.0.3.68

12.0.4.12

12.3.0.119

UDI:

0735000201042620211208

0735000201049520220312

0735000201050120220422

0735000201060020220620

0735000201057020221222

GTIN:

07350002010426

07350002010495

07350002010501

07350002010600

07350002010570

Date Ranges: Expiration Date: 2028-03-20

Recall number Z-1190-2025

Product: RayStation Radiation Therapy Treatment Planning System

Variants: RayStation 12A, RayStation 12A Service Pack 1, RayStation 12A Service Pack 2, RayStation 2023B

Model / REF:

13.0.0.1547

13.1.0.144

13.1.1.89

14.0.0.3338

Serial Numbers:

13.0.0.1547

13.1.0.144

13.1.1.89

14.0.0.3338

UDI:

0735000201054920220616

0735000201067920221007

0735000201073020230913

0735000201055620230630

GTIN:

07350002010549

07350002010679

07350002010730

07350002010556

Date Ranges: Expiration Date: 2028-07-07

Recall number Z-1191-2025

Product: RayStation Radiation Therapy Treatment Planning System

Variants: RayStation 6 Service Pack 1, RayStation 6 Service Pack 2, RayStation 6 Service Pack 3

Model / REF:

6.1.1.2

6.2.0.7

6.3.0.6

Serial Numbers:

6.1.1.2

6.2.0.7

6.3.0.6

UDI:

0735000201008220170529

0735000201007520170630

0735000201024220190923

GTIN:

07350002010082

07350002010075

07350002010242

Date Ranges: Expiration Date: 2024-10-18

Recall number Z-1192-2025

Product: RayStation Radiation Therapy Treatment Planning System

Variants: RayStation 6

Model / REF:

6.0.0.24

Serial Numbers:

6.0.0.24

UDI:

00735000201001320161214

GTIN:

07350002010013

Date Ranges: Expiration Date: 2021-12-22

Recall number Z-1193-2025

Product: RayStation Radiation Therapy Treatment Planning System

Variants: RayStation 5 Service Pack 2, RayStation 5 Service Pack 3

Model / REF:

5.0.2.35

5.0.3.17

Serial Numbers:

5.0.2.35

5.0.3.17

UDI:

0735000201002020170502

GTIN:

07350002010020

Date Ranges: Expiration Date: 2028-12-21

Recall number Z-1194-2025

Product: RayStation Radiation Therapy Treatment Planning System

Variants: RayStation 4.5.1, RayStation 4.7.2, RayStation 4.7.3, RayStation 4.7.4, RayStation 4.7.5, RayStation 4.7.6

Model / REF:

4.5.1.14

4.7.2.5

4.7.3.13

4.7.4.4

4.7.5.4

4.7.6.7

Serial Numbers:

4.5.1.14

4.7.2.5

4.7.3.13

4.7.4.4

4.7.5.4

4.7.6.7

Date Ranges: Expiration Date: 2025-03-17

Recall number Z-1195-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96156

Status: Active

Manufacturer: RAYSEARCH LABORATORIES AB

Sold By: Authorized Medical Device Distributors; Direct Sales from RaySearch Laboratories

Manufactured In: Sweden

Units Affected: 11 products (0; 1; 1; 0; 6; 5; 32; 1; 0; 0; 0)

Distributed To: Nationwide