--- title: "RAYSEARCH LABORATORIES AB Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search RAYSEARCH LABORATORIES AB recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/raysearch-laboratories-ab/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # RAYSEARCH LABORATORIES AB recall records **48** reported ongoing 50 records in this archive. Latest source date May 20, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status May 20, 2026 FDA device enforcement ### [RayCare 2024A SP1. Oncology Information Systems.](https://isitonrecall.com/recall/fda-device-z-2646-2026-raycare-2024a-sp1-oncology-information-systems/) 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. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for RayCare 2024A SP1. Oncology Information Systems.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2646-2026%22) May 20, 2026 FDA device enforcement ### [RayCare 2024A SP4. Oncology Information Systems.](https://isitonrecall.com/recall/fda-device-z-2647-2026-raycare-2024a-sp4-oncology-information-systems/) 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. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for RayCare 2024A SP4. Oncology Information Systems.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2647-2026%22) Nov 28, 2025 FDA device enforcement ### [RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System](https://isitonrecall.com/recall/fda-device-z-1102-2026-raystation-rayplan-model-catalog-number-10-1-software-version-raystation-rayplan-10b-radiation-thera/) 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, Fixati... Class II Reported ongoing Distribution: Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS [Official source for RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiati...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1102-2026%22) Nov 28, 2025 FDA device enforcement ### [RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2, RayStation 11A SP3. Radiatio...](https://isitonrecall.com/recall/fda-device-z-1103-2026-raystation-rayplan-model-catalog-numbers-11-0-0-11-0-1-11-0-3-11-0-4-software-version-raystation-11a/) 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, Fixati... Class II Reported ongoing Distribution: Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS [Official source for RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayS...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1103-2026%22) Nov 28, 2025 FDA device enforcement ### [RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1, RayStation 11B SP2, RayStation 11B SP3, ...](https://isitonrecall.com/recall/fda-device-z-1104-2026-raystation-rayplan-model-catalog-numbers-12-0-0-12-1-0-12-0-3-12-0-4-12-3-0-software-version-raystat/) 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, Fixati... Class II Reported ongoing Distribution: Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS [Official source for RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Versi...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1104-2026%22) Nov 28, 2025 FDA device enforcement ### [Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A, RayStation 12A SP1, RayStation...](https://isitonrecall.com/recall/fda-device-z-1105-2026-brand-name-raystation-product-name-raystation-rayplan-model-catalog-number-13-0-0-1547-13-1-0-144-13/) 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, Fixati... Class II Reported ongoing Distribution: Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS [Official source for Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1105-2026%22) Nov 28, 2025 FDA device enforcement ### [Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3 P...](https://isitonrecall.com/recall/fda-device-z-1106-2026-brand-name-raystation-product-name-raystation-rayplan-model-catalog-number-14-0-0-15-0-0-15-1-3-soft/) 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, Fixati... Class II Reported ongoing Distribution: Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS [Official source for Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15....](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1106-2026%22) Nov 28, 2025 FDA device enforcement ### [Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatment Planni...](https://isitonrecall.com/recall/fda-device-z-1107-2026-brand-name-raystation-product-name-raystation-rayplan-model-catalog-number-10-1-1-software-version-r/) 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, Fixati... Class II Reported ongoing Distribution: Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS [Official source for Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Ver...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1107-2026%22) Nov 28, 2025 FDA device enforcement ### [Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Ra...](https://isitonrecall.com/recall/fda-device-z-1108-2026-brand-name-raystation-product-name-raystation-rayplan-model-catalog-number-15-2-0-15-1-3-software-ve/) 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, Fixati... Class II Reported ongoing Distribution: Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS [Official source for Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Soft...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1108-2026%22) Nov 28, 2025 FDA device enforcement ### [Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radiation Therapy Treatment Planning...](https://isitonrecall.com/recall/fda-device-z-1109-2026-brand-name-raystation-product-name-raystation-rayplan-model-catalog-number-16-0-0-software-version-r/) 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, Fixati... Class II Reported ongoing Distribution: Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS [Official source for Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Ver...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1109-2026%22) Nov 28, 2025 FDA device enforcement ### [Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation v2025 SP1 Product Description: Radiat...](https://isitonrecall.com/recall/fda-device-z-1110-2026-brand-name-raystation-product-name-raystation-rayplan-model-catalog-number-17-0-0-17-0-1-software-ve/) 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, Fixati... Class II Reported ongoing Distribution: Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS [Official source for Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Soft...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1110-2026%22) Aug 8, 2025 FDA device enforcement ### [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, S...](https://isitonrecall.com/recall/fda-device-z-2487-2025-raystation-with-the-following-product-descriptions-1-raystation-7-software-version-7-0-0-19-2-raysta/) DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique. Class II Reported ongoing 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, Fran... [Official source for RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2487-2025%22) Aug 8, 2025 FDA device enforcement ### [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 Se...](https://isitonrecall.com/recall/fda-device-z-2488-2025-raystation-with-the-following-product-descriptions-1-raystation-8b-software-version-8-1-0-47-2-rayst/) DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique. Class II Reported ongoing 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, Fran... [Official source for RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47....](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2488-2025%22) Aug 8, 2025 FDA device enforcement ### [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 10...](https://isitonrecall.com/recall/fda-device-z-2489-2025-raystation-with-the-following-product-descriptions-1-raystation-9b-software-version-9-1-0-933-2-rays/) DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique. Class II Reported ongoing 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, Fran... [Official source for RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2489-2025%22) Aug 8, 2025 FDA device enforcement ### [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 Descr...](https://isitonrecall.com/recall/fda-device-z-2490-2025-raystation-with-the-following-product-descriptions-1-raystation-10b-software-version-10-1-0-613-2-ra/) DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique. Class II Reported ongoing 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, Fran... [Official source for RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.6...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2490-2025%22) Aug 8, 2025 FDA device enforcement ### [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...](https://isitonrecall.com/recall/fda-device-z-2491-2025-raystation-with-the-following-product-descriptions-1-raystation-11a-software-version-11-0-0-951-2-ra/) DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique. Class II Reported ongoing 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, Fran... [Official source for RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.9...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2491-2025%22) Aug 8, 2025 FDA device enforcement ### [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. RayStati...](https://isitonrecall.com/recall/fda-device-z-2492-2025-raystation-with-the-following-product-descriptions-1-raystation-11b-software-version-12-0-0-932-2-ra/) DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique. Class II Reported ongoing 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, Fran... [Official source for RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.9...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2492-2025%22) Aug 8, 2025 FDA device enforcement ### [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. RayStati...](https://isitonrecall.com/recall/fda-device-z-2493-2025-raystation-with-the-following-product-descriptions-1-raystation-12a-software-version-13-0-0-1547-2-r/) DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique. Class II Reported ongoing 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, Fran... [Official source for RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2493-2025%22) Aug 8, 2025 FDA device enforcement ### [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. RayS...](https://isitonrecall.com/recall/fda-device-z-2494-2025-raystation-with-the-following-product-descriptions-1-raystation-6-service-pack-1-software-version-6/) DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique. Class II Reported ongoing 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, Fran... [Official source for RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Vers...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2494-2025%22) Aug 8, 2025 FDA device enforcement ### [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 SP...](https://isitonrecall.com/recall/fda-device-z-2495-2025-raystation-with-the-following-product-descriptions-1-raystation-2023b-software-version-14-0-0-3338-2/) DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique. Class II Reported ongoing 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, Fran... [Official source for RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2495-2025%22) ## Reasons in these listed records - 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. - 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 t... - 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 examples come from this result page and are not a ranking of every recall reason. ## Checking RAYSEARCH LABORATORIES AB ### Is there a recall on raysearch laboratories ab right now? This archive contains 50 records, including 48 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search RAYSEARCH LABORATORIES AB](https://isitonrecall.com/check/?q=RAYSEARCH%20LABORATORIES%20AB) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)