RAYSEARCH LABORATORIES AB 2025-09-10 Health serious FDA
Health · FDA · Recall #FDA-Z-2488-2025
RayStation with the following product descriptions: 1. RayStation 8B, Software… Recall
Issued September 10, 2025 · RAYSEARCH LABORATORIES AB
In September 2025, RAYSEARCH LABORATORIES AB recalled the RayStation with the following product descriptions: 1. RayStation 8B, Software…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using RayStation with the following product descriptions: 1. RayStation 8B, Software… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact RAYSEARCH LABORATORIES AB to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- RAYSEARCH LABORATORIES AB
- Category
- Health
- Recall date
- September 10, 2025
- Units affected
- Not reported
- Sold at
- 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 count
- Recall number
- FDA-Z-2488-2025
- Made in
- Sweden
- Issuing agency
- FDA
In context
- RAYSEARCH LABORATORIES AB has 9 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.