SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.
FDA Recall Z-2107-2016 · Posted None
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-06-06
Date Terminated2017-01-17
Product Quantity29 units
Reason for Recall
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).
Firm Action
Siemens mailed customers a letter to inform them about improvements that were made to the SYNGO Breast Care reading software to correct certain behaviors that were being seen during use. Customers were asked to upgrade their systems to this new version.
Root Cause
Other
Distribution Pattern
Distributed to: CA,NY,TX,OH,CO,NY,TX,CA,NE,NJ,TX,FL,IL,TX,MO,CA,PA,FL,NJ,MO,ND
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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