Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 7/6/2016
Class lI:

PRODUCT

SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.,
Recall Number Z-2107-2016

REASON
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).

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 6/62016. Voluntary: Firm Initiated recall is onging.

VOLUME OF PRODUCT IN COMMERCE
29 systems

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

___________________________________