RayStation 9B and 10A software recalled over non-unique DICOM identifiers
RayStation 9B, 9B SP1, 10A and 10A service pack 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 9B, software version 9.1.0.933, RayStation 9B Service Pack 1, software version 9.2.0.483, RayStation 10A, software version 10.0.0.1154, and the RayStation 10A service pack listed in the notice. The recall covers 26 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 9B, Software Version: 9.1.0.933. 2. RayStation 9B Service Pack 1, Software Version: 9.2.0.483. 3. RayStation 10A, Software Version: 10.0.0.1154. 4. RayStation 10A Service Pack 1, Software Version: 10.0
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Affected units
- 26
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 (6)
- 1. Software Version: 9.1.0.933
- UDI: 0735000201026620191220. 2. Software Version: 9.2.0.483
- UDI: 0735000201029720200310. 3. Software Version: 10.0.0.1154
- UDI: 0735000201030320200526. 4. Software Version: 10.0.1.52
- UDI: 0735000201036520200526. 5. Software Version: 10.0.2.10
- UDI: 0735000201065520220608. Expiration Date: 2025-06-16
Distribution
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.
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