Siemens Medical Solutions USA, Inc recalls ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator sy…

Recall date

July 26, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2876-2016

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Nationwide distribution

Why it was recalled

Software patch installation to address several safety issues.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.