Siemens Medical Solutions USA Inc. recalls BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Co…

Recall date

April 25, 2016

Source

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

Recall number

Z-2000-2016

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA Inc.

Sold / distributed

Worldwide Distribution - US Nationwide and the countries of China and Malaysia.

Why it was recalled

The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.

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

What was recalled

BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.