Siemens Medical Solutions USA, Inc. recalls Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolut…

Recall date

February 21, 2018

Source

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

Recall number

Z-1930-2018

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc.

Sold / distributed

Domestic distribution to . International distribution to Finland, France, France, Iran, Ireland, Italy, Japan, Japan, Netherlands.

Why it was recalled

Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET cardiac gating examinations may experience a waveform sampling issue caused by a firmware change within the Universal Physiological Measurement Module.

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 Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.