Z-2494-2025Class II

RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version...

Name: Z-2494-2025 RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version...
Creator: Raysearch Laboratories Ab
Published: 2025-08-08
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2025-08-08 / Open, Classified

FDA source

RAYSEARCH LABORATORIES AB began a recall of 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... on 2025-08-08. FDA classified it as Class II and gives the reason as "DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2494-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-08
Posted: 2025-09-02
Recalling firm: RaySearch Laboratories AB (publ)
Product: 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.
Product code: MUJ System, Planning, Radiation Therapy Treatment
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.
FDA root cause: Under Investigation by firm
Action: RaySearch notified consignees on about 08/08/2025 via email. Consignees were informed that as temporary solution, affected objects can be re-exported via RayGateway to generate new UIDs. They were instructed to inform planning staff and all users about this workaround, inspect your product and identify all installed units with the above software version number(s), and complete and return the response form. The issue will be resolved in the next version of RayStation, scheduled for market release in December 2025 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation affected by this notice, all users must maintain awareness of this notice. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use.
Quantity in commerce: 0
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, France, Germany, Hong Kong S.A.R., China, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, ENG, Thailand, Turkey, UK, Ukraine.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2494-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2487-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-02
Z-2488-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-02
Z-2489-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-02
Z-2490-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-02
Z-2491-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-02
Z-2492-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-02
Z-2493-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-02
Z-2494-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-02
Z-2495-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-02

Product code MUJ

K171536Class IIRayStationRaySearch Laboratories AB (PUBL) / cleared 2017-06-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)