Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2490-2025·Announced 2025-09-10

RayStation 10B planning software recalled over DICOM identifiers not guaranteed unique

RayStation 10B and 10B Service Pack 1 radiation therapy treatment planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.

The agency’s classification

FDA (Devices): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Rubric level 2 covers precautionary recalls; the notice describes a software identifier uniqueness issue without stating any patient consequence.

Plain-English summary

RayStation radiation therapy treatment planning system software is being recalled in two versions: RayStation 10B, software version 10.1.0.613, and RayStation 10B Service Pack 1, software version 10.1.1.54. The recall covers 3 installations distributed nationwide in the United States and internationally.

The recall was issued because the DICOM SOP Instance UID and Series Instance UID from RayGateway, the interface to Accuray's iDMS, are not guaranteed to be unique. The FDA classified the action as Class II. The notice does not describe a further consequence.

Radiotherapy centres running these versions should follow the manufacturer's instructions for the software correction.

The recalled product

Product: 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.
Manufacturer: RAYSEARCH LABORATORIES AB
Category: Medical Device — Radiation Therapy
Hazard: software-defect
dicom-identifiers
treatment-planning
class-ii
Affected units: 3

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Part of a larger recall action

This product is one of 9 recalled by RAYSEARCH LABORATORIES AB under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Same manufacturer · RAYSEARCH LABORATORIES AB

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