PlainRecalls
FDA Devices Moderate Class II Ongoing

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: 10.0.1.52. 5. RayStation 10A Service Pack 2, Software Version: 10.0.2.10. Product Description: Radiation Therapy Treatment Planning System.

Reported: September 10, 2025 Initiated: August 8, 2025 #Z-2489-2025

Product Description

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: 10.0.1.52. 5. RayStation 10A Service Pack 2, Software Version: 10.0.2.10. Product Description: Radiation Therapy Treatment Planning System.

Reason for Recall

DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

Details

Recalling Firm
RAYSEARCH LABORATORIES AB
Units Affected
26
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.
Location
Stockholm, N/A

Frequently Asked Questions

What product was recalled? ▼
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: 10.0.1.52. 5. RayStation 10A Service Pack 2, Software Version: 10.0.2.10. Product Description: Radiation Therapy Treatment Planning System.. Recalled by RAYSEARCH LABORATORIES AB. Units affected: 26.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 10, 2025. Severity: Moderate. Recall number: Z-2489-2025.

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