Device recall: RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment…

Class II FDA enforcement event 98117. Recall start date: 28 Nov 2025. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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…

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

RAYSEARCH LABORATORIES AB started this device recall on 28 Nov 2025. The firm address in the FDA record is in Stockholm. FDA put the recall in Class II. FDA event 98117 has 9 product records. The first FDA enforcement report date is 28 Jan 2026. The record gives the status Ongoing.

FDA enforcement report The 9 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS

Recalling firm

RAYSEARCH LABORATORIES AB, Stockholm, Sweden.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

9 product records in the event.

FDA event 98117: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1102-2026	RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System	0	Class II	Ongoing	28 Jan 2026
Z-1103-2026	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. Radiation Therapy Treatment Planning System	10 units	Class II	Ongoing	28 Jan 2026
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: RayStation 11B, RayStation 11B SP1, RayStation 11B SP2, RayStation 11B SP3, RayStation 11B SPT1. Radiation Therapy Treatment Planning System	22 units	Class II	Ongoing	28 Jan 2026
Z-1105-2026	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 12A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No	8	Class II	Ongoing	28 Jan 2026
Z-1106-2026	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 Product Description: Radiation Therapy Treatment Planning System Component: No	119	Class II	Ongoing	28 Jan 2026
Z-1107-2026	Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatment Planning System Component: No	0	Class II	Ongoing	28 Jan 2026
Z-1108-2026	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: Radiation Therapy Treatment Planning System Component: No	0	Class II	Ongoing	28 Jan 2026
Z-1109-2026	Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radiation Therapy Treatment Planning System Component: No	0	Class II	Ongoing	28 Jan 2026
Z-1110-2026	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: Radiation Therapy Treatment Planning System Component: No	0	Class II	Ongoing	28 Jan 2026

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2025: 945
Share of these events in Class II: 85%
Product records in this event: 9Median of the firm: 1
Events of the firm on the register: 57

Other events of the firm

Other FDA enforcement events of RAYSEARCH LABORATORIES AB
Initiated	Product (first record)	Type	Class	Records
20 May 2026	RayCare 2024A SP1. Oncology Information Systems.	Device	Class II	2
8 Aug 2025	RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. 2. RayStation 8A, Softw	Device	Class II	9
16 Jan 2025	Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0.0.	Device	Class II	11
28 Mar 2024	RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.	Device	Class II	12
23 Feb 2024	RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including som	Device	Class II	1
12 Sep 2023	RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as w	Device	Class II	1
17 Jul 2023	RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to supp	Device	Class II	1
17 Feb 2023	Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10	Device	Class II	1
10 Jun 2022	RayStation 11B	Device	Class II	1
1 Jun 2022	RayStation 9B SP1. For radiation treatment planning.	Device	Class II	1

RAYSEARCH LABORATORIES AB: all 57 events

Official channels

FDA enforcement report Z-1102-2026The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 98117. https://recallregister.com/fda/ii/98117/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
What quantity of product is in FDA event 98117?: The event has 9 product records. The first record gives this quantity: 0
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2025 have the same class?: 85% of the 945 device events that started in 2025 are in Class II.