The Recall Desk
ModerateFDA (Devices)·Z-2487-2025·Announced 2025-09-10

RayStation 7 and 8A software recalled over DICOM instance identifier defect

RayStation 7, 8A and 8A Service Pack 1 radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.

What this means for you

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 across RayStation 7, software version 7.0.0.19, RayStation 8A, software version 8.0.0.61, and RayStation 8A Service Pack 1, software version 8.0.1.10. The recall covers 1 installation 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 7, Software Version: 7.0.0.19. 2. RayStation 8A, Software Version: 8.0.0.61. 3. RayStation 8A Service Pack 1, Software Version: 8.0.1.10. Product Description: Radiation Therapy Treatment Planning Sys
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy
Hazard
Affected units
1

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 (4)

  • 1. Software Version: 7.0.0.19
  • UDI: 0735000201006820171130. 2. Software Version: 8.0.0.61
  • UDI: 0735000201011220180608. 3. Software Version: 8.0.1.10
  • UDI: 0735000201013620180928. Expiration Date: 2023-10-04

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 →

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