RAYSEARCH LABORATORIES AB — RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1, Software Version: 12.1.0.1221.

Is this relevant to me?

Geography

Nationwide

Source agency

FDA

Category

Health

Published

August 8, 2025

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.

What's affected?

Product

RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1, Software Version: 12.1.0.1221. 3. RayStation 11B Service Pack 2, Software Version: 12.0.3.68. 4. RayStation 11B Service Pack 3, Software Version: 12.0.4.12. 5. RayStation 11B Service Pack Toshiba 1, Software Version: 12.3.0.119. Product Description: Radiation Therapy Treatment Planning System.

Brand

RAYSEARCH LABORATORIES AB

Lot code

1. Software Version: 12.0.0.932, UDI: 0735000201042620211208. 2. Software Version: 12.1.0.1221, UDI: 0735000201049520220312. 3. Software Version: 12.0.3.68, UDI: 0735000201050120220422. 4. Software Version: 12.0.4.12, UDI: 0735000201060020220620. 5. Software Version: 12.3.0.119, UDI: 0735000201057020221222. Expiration Date: 2028-03-20

What should I do?