Class II — Potential Health Hazard

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

ARTISTE with syngo RT Therapist version 4.3 Product Usage: The Recalled by Siemens Medical Solutions USA, Inc Due to The potential for a safety issue, for the...

Date: May 29, 2013
Company: Siemens Medical Solutions USA, Inc
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 Siemens Medical Solutions USA, Inc directly.

Affected Products

ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use of the SIEMENS branded ARTISTE family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

Quantity: 8 units

Why Was This Recalled?

The potential for a safety issue, for the image quality degradation, that is addressed by the Customer Safety Advisory Notice when verifying the patient position based on 2D images that were acquired as single-exposure MV or In-Line kView images using the syngo RT Therapist 4.3.

Where Was This Sold?

Worldwide distribution

About Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc has 20 total recalls tracked by RecallDetector.

Related Recalls

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