FDA recall Z-2492-2025

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.

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.

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.

Key facts

Status

Ongoing

Initiation date

2025-08-08

Report date

2025-09-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Stockholm, N/A, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2492-2025