Recall Z-2107-2016 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.
| Date | Jun 6, 2016 |
| Status | Terminated |
| 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). |
| Root cause | Other |
| 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. |
| Quantity | 29 units |
| Distribution | Distributed to: CA,NY,TX,OH,CO,NY,TX,CA,NE,NJ,TX,FL,IL,TX,MO,CA,PA,FL,NJ,MO,ND |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123420 | SYNGO, BREAST CARE Siemens Medical Solutions USA, Inc., Feb 1, 2013 |