Siemens Medical Solutions USA, Inc recalls SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography im…

Recall date

June 6, 2016

Source

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

Recall number

Z-2107-2016

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Distributed to: CA,NY,TX,OH,CO,NY,TX,CA,NE,NJ,TX,FL,IL,TX,MO,CA,PA,FL,NJ,MO,ND

Why it was recalled

Software issues. Siemens is voluntarily initiating a recall after they became aware of the following system behavior: 1) At times, the view and laterality marker is overlaid by patient demographic information, thus becoming difficult to read. 2) The facility name and address are not shown per default (in the current software versions this information is displayed only when the reader chooses an appropriate image text display mode).

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

What was recalled

SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.