RAYSEARCH LABORATORIES AB: Medical Device Recall in 2025 - (Recall #: Z-1188-2025)

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:

Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: RayStation 10B and 10B Service Pack 1

Product Classification:

Class II

Date Initiated: January 16, 2025

Date Posted: February 26, 2025

Recall Number: Z-1188-2025

Event ID: 96156

Reason for Recall:

Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.

Status: Ongoing

Product Quantity: 0

Code Information:

Lot Code: UDI: 0735000201031020201216 and 0735000201047120220128 GTIN: 07350002010310 and 07350002010471 Serial Numbers: 10.1.0.613 and 10.1.1.54 Software Revisions: RayStation 10B and 10B Service Pack 1 Expiration Date: 2027-02-01

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Belgium ENG, Canada, China, China APactron, Denmark, France, Germany, Hong Kong S.A.R. China, India, Italy, Japan, Korea, Netherlands, Norway, Poland, Singapore, Spain, SwitzerlandENG, Taiwan, Thailand, UK.

Voluntary or Mandated:

Voluntary: Firm initiated