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 3.5 Recalled by RAYSEARCH LABORATORIES AB Due to Isocenter shifts when using dose tracking in RayStation...

Date: November 12, 2018
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 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A

Quantity: 69

Why Was This Recalled?

Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A. In these versions, isocenter shifts in dose tracking are incorrectly interpreted according to the DICOM patient coordinate system.

Where Was This Sold?

This product was distributed to 30 states: AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, LA, ME, MD, MA, MI, MS, MO, NJ, NY, NC, OH, OR, PA, RI, TN, TX, VT, VA, WA, WI

Affected (30 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