RAYSEARCH LABORATORIES AB: Medical Device Recall in 2025 - (Recall #: Z-2490-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pack 1, Software Version: 10.1.1.54. Product Description: Radiation Therapy Treatment Planning System.

Product Classification:

Class II

Date Initiated: August 8, 2025

Date Posted: September 10, 2025

Recall Number: Z-2490-2025

Event ID: 97400

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.

Status: Ongoing

Product Quantity: 3

Code Information:

1. Software Version: 10.1.0.613, UDI: 0735000201031020201216. 2. Software Version: 10.1.1.54, UDI: 0735000201047120220128. Expiration Date: 2027-02-01

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated