Siemens Medical Solutions USA, Inc recalls Artis Q.zen biplane, Material no. 10848355, for angiography and whole body radiographic/fluoroscopic procedures.

Recall date

May 1, 2018

Source

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

Recall number

Z-2305-2018

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Worldwide distribution. US nationwide including Puerto Rico, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Luxembourg, Mexico, Myanmar, Netherlands, New…

Why it was recalled

After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, the system cannot be operated normally. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.

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 Q.zen biplane, Material no. 10848355, for angiography and whole body radiographic/fluoroscopic procedures.