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 standalone software radiation therapy treatment planning system. Model Number: Recalled by RAYSEARCH LABORATORIES AB Due to When using more than one plan in a...

Date: April 7, 2021
Company: RAYSEARCH LABORATORIES AB
Status: Terminated
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 standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs

Quantity: N/A

Why Was This Recalled?

When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose tracking and the fractions that are included in the dose summation. The issue only affects RayTreat users and only the Total dose option. Accumulation and other options in Dose tracking are correct.

Where Was This Sold?

This product was distributed to 1 state: TN

Affected (1 state)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