The Recall Desk
ModerateFDA (Devices)·Z-2491-2025·Announced 2025-09-10

RayStation 11A planning software recalled over non-unique DICOM instance identifiers

RayStation 11A and its service packs are recalled because DICOM instance identifiers from the RayGateway interface to Accuray's iDMS 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 11A, software version 11.0.0.951, RayStation 11A Service Pack 1, software version 11.0.1.29, RayStation 11A Service Pack 2, software version 11.0.3.116, and further versions listed in the recall notice. 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 11A, Software Version: 11.0.0.951. 2. RayStation 11A Service Pack 1, Software Version: 11.0.1.29. 3. RayStation 11A Service Pack 2, Software Version: 11.0.3.116. 4. RayStation 11A Service Pack 3, Softw
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy
Hazard
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 (5)

  • 1. Software Version: 11.0.0.951
  • UDI: 0735000201038920210518. 2. Software Version: 11.0.1.29
  • UDI: 0735000201043320210610. 3. Software Version: 11.0.3.116
  • UDI: 0735000201044020210916. 4. Software Version: 11.0.4.15
  • UDI: 0735000201063120220616. Expiration Date: 2027-06-22

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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