Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

RayStation with the following product descriptions: 1. RayStation 6 Service Recalled by RAYSEARCH LABORATORIES AB Due to DICOM SOP Instance UID and Series Instance UID...

Date: August 8, 2025
Company: RAYSEARCH LABORATORIES AB
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact RAYSEARCH LABORATORIES AB directly.

Affected Products

RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2. RayStation 6 Service Pack 2, Software Version: 6.2.0.7. 3. RayStation 6 Service Pack 3, Software Version: 6.3.0.6. Product Description: Radiation Therapy Treatment Planning System.

Quantity: 0

Why Was This Recalled?

DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About RAYSEARCH LABORATORIES AB

RAYSEARCH LABORATORIES AB has 113 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report