Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97400

9 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 08, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
RAYSEARCH LABORATORIES AB

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

9 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 9

RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. 2. RayStation 8A, Software Version: 8.0.0.61. 3. RayStation 8A Service Pack 1, Software Version: 8.0.1.10. Product Description: Radiation Therapy Treatment Planning System.

Z-2487-2025
Recall number
Z-2487-2025
Initiated
August 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

Code information

1. Software Version: 7.0.0.19, UDI: 0735000201006820171130. 2. Software Version: 8.0.0.61, UDI: 0735000201011220180608. 3. Software Version: 8.0.1.10, UDI: 0735000201013620180928. Expiration Date: 2023-10-04

Distribution pattern

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, UK, Ukraine.

device · product 2 of 9

RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1, Software Version: 8.1.1.8. 3. RayStation 8B Service Pack 2, Software Version: 8.1.2.5. 4. RayStation 9A, Software Version: 9.0.0.113. 5. RayStation 9A Service Pack 1, Software Version: 9.0.1.142. Product Description: Radiation Therapy Treatment Planning System.

Z-2488-2025
Recall number
Z-2488-2025
Initiated
August 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

Code information

1. Software Version: 8.1.0.47, UDI: 0735000201012920181209. 2. Software Version: 8.1.1.8, UDI: 0735000201020420190214. 3. Software Version: 8.1.2.5, UDI: 0735000201023520190524. 4. Software Version: 9.0.0.113, UDI: 0735000201017420190612. 5. Software Version: 9.0.1.142, UDI: 0735000201048820220420. Expiration Date: 2027-12-15

Distribution pattern

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, UK, Ukraine.

device · product 3 of 9

RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation 9B Service Pack 1, Software Version: 9.2.0.483. 3. RayStation 10A, Software Version: 10.0.0.1154. 4. RayStation 10A Service Pack 1, Software Version: 10.0.1.52. 5. RayStation 10A Service Pack 2, Software Version: 10.0.2.10. Product Description: Radiation Therapy Treatment Planning System.

Z-2489-2025
Recall number
Z-2489-2025
Initiated
August 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
26

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

Code information

1. Software Version: 9.1.0.933, UDI: 0735000201026620191220. 2. Software Version: 9.2.0.483, UDI: 0735000201029720200310. 3. Software Version: 10.0.0.1154, UDI: 0735000201030320200526. 4. Software Version: 10.0.1.52, UDI: 0735000201036520200526. 5. Software Version: 10.0.2.10, UDI: 0735000201065520220608. Expiration Date: 2025-06-16

Distribution pattern

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, UK, Ukraine.

device · product 4 of 9

RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pack 1, Software Version: 10.1.1.54. Product Description: Radiation Therapy Treatment Planning System.

Z-2490-2025
Recall number
Z-2490-2025
Initiated
August 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
3

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

Code information

1. Software Version: 10.1.0.613, UDI: 0735000201031020201216. 2. Software Version: 10.1.1.54, UDI: 0735000201047120220128. Expiration Date: 2027-02-01

Distribution pattern

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, UK, Ukraine.

device · product 5 of 9

RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStation 11A Service Pack 1, Software Version: 11.0.1.29. 3. RayStation 11A Service Pack 2, Software Version: 11.0.3.116. 4. RayStation 11A Service Pack 3, Software Version: 11.0.4.15. Product Description: Radiation Therapy Treatment Planning System.

Z-2491-2025
Recall number
Z-2491-2025
Initiated
August 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
3

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

Code information

1. Software Version: 11.0.0.951, UDI: 0735000201038920210518. 2. Software Version: 11.0.1.29, UDI: 0735000201043320210610. 3. Software Version: 11.0.3.116, UDI: 0735000201044020210916. 4. Software Version: 11.0.4.15, UDI: 0735000201063120220616. Expiration Date: 2027-06-22

Distribution pattern

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, UK, Ukraine.

device · product 6 of 9

RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1, Software Version: 12.1.0.1221. 3. RayStation 11B Service Pack 2, Software Version: 12.0.3.68. 4. RayStation 11B Service Pack 3, Software Version: 12.0.4.12. 5. RayStation 11B Service Pack Toshiba 1, Software Version: 12.3.0.119. Product Description: Radiation Therapy Treatment Planning System.

Z-2492-2025
Recall number
Z-2492-2025
Initiated
August 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
6

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

Code information

1. Software Version: 12.0.0.932, UDI: 0735000201042620211208. 2. Software Version: 12.1.0.1221, UDI: 0735000201049520220312. 3. Software Version: 12.0.3.68, UDI: 0735000201050120220422. 4. Software Version: 12.0.4.12, UDI: 0735000201060020220620. 5. Software Version: 12.3.0.119, UDI: 0735000201057020221222. Expiration Date: 2028-03-20

Distribution pattern

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, UK, Ukraine.

device · product 7 of 9

RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pack 1, Software Version: 13.1.0.144. 3. RayStation 12A Service Pack 2, Software Version: 13.1.1.89. Product Description: Radiation Therapy Treatment Planning System.

Z-2493-2025
Recall number
Z-2493-2025
Initiated
August 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
13

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

Code information

1. Software Version: 13.0.0.1547, UDI: 0735000201054920220616. 2. Software Version: 13.1.0.144, UDI: 0735000201067920221007. 3. Software Version: 13.1.1.89, UDI: 0735000201073020230913. Expiration Date: 2028-07-07

Distribution pattern

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, UK, Ukraine.

device · product 8 of 9

RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2. RayStation 6 Service Pack 2, Software Version: 6.2.0.7. 3. RayStation 6 Service Pack 3, Software Version: 6.3.0.6. Product Description: Radiation Therapy Treatment Planning System.

Z-2494-2025
Recall number
Z-2494-2025
Initiated
August 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
0

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

Code information

1. Software Version: 6.1.1.2, UDI: 0735000201008220170529. 2. Software Version: 6.2.0.7, UDI: 0735000201007520170630. 3. Software Version: 6.3.0.6, UDI: 0735000201024220190923. Expiration Date: 2024-10-18

Distribution pattern

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, UK, Ukraine.

device · product 9 of 9

RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RayStation 2024A, Software Version: 15.0.0.430. 3. RayStation 2024A SP3, Software Version: 15.1.3.10. Product Description: Radiation Therapy Treatment Planning System.

Z-2495-2025
Recall number
Z-2495-2025
Initiated
August 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
49

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

Code information

1. Software Version: 14.0.0.3338, UDI: 0735000201055620230630. 2. Software Version: 15.0.0.430, UDI: 0735000201072320231213. 3. Software Version: 15.1.3.10, UDI: 0735000201087720241106. Expiration Date: 2030-02-21

Distribution pattern

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, UK, Ukraine.