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 MV System Recalled by Siemens Medical Solutions USA, Inc Due to There may be an existing dark current phenomenon...

Date: November 19, 2014
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 MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.

Quantity: 3

Why Was This Recalled?

There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mARC treatments using unflat beams. Software issue.

Where Was This Sold?

This product was distributed to 3 states: NY, UT, WI

Affected (3 states)Not affected

About Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc has 613 total recalls tracked by RecallDetector.

Related Recalls

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