FDA Medical devices recall ·
RayStation with the following product descriptions: 1… recall
- Recall number
- Z-2488-2025
- Date
- (initiated August 8, 2025)
- Company / brand
- Raysearch Laboratories Ab
Eugeniavagen 18c, Stockholm, N/A, Sweden - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1, Software Version: 8.1.1.8. 3. RayStation 8B Service Pack 2, Software Version: 8.1.2.5. 4. RayStation 9A, Software Version: 9.0.0.113. 5. RayStation 9A Service Pack 1, Software Version: 9.0.1.142. Product Description: Radiation Therapy Treatment Planning System.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1. Software Version: 8.1.0.47, UDI: 0735000201012920181209. 2. Software Version: 8.1.1.8, UDI: 0735000201020420190214. 3. Software Version: 8.1.2.5, UDI: 0735000201023520190524. 4. Software Version: 9.0.0.113, UDI: 0735000201017420190612. 5. Software Version: 9.0.1.142, UDI: 0735000201048820220420. Expiration Date: 2027-12-15
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.
States: Alabama California Florida Georgia Iowa Illinois Kentucky Louisiana Maryland Minnesota Mississippi North Carolina New York Ohio Oklahoma South Carolina Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2488-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.