Siemens Medical Solutions USA, Inc recalls Artis zee, Angiographic x-ray system

Recall date

March 28, 2017

Source

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

Recall number

Z-1824-2017

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Distributed to: VA, CA, WI

Why it was recalled

Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following the failure of a tube assembly focus, the Artis system functions properly until the next reactivation. Following reactivation, the system no longer initializes as intended.

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

What was recalled

Artis zee, Angiographic x-ray system