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RayStation with the following product descriptions recallZ-2488-2025 · Raysearch Laboratories AB · initiated Aug 8, 2025

Class II Open, Classified All recalls posted in September 2025

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Raysearch Laboratories AB or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-2488-2025
Recall class
Class II
Status
Open, Classified
Initiated by the company
Aug 8, 2025
Posted by the FDA
Sep 2, 2025
Recalling firm
Raysearch Laboratories AB
Quantity
2
Product code
MUJ
FDA submissions
K190387
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 description

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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

2 devices cleared under K190387 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 97400).

Sources and updates

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