FDA Device recall Z-2107-2016
SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthes…
- FDA Device
- Class II
- terminated
- Published 2016-07-06
On 2016-07-06 the FDA classified a Class II recall of SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthes… by Siemens Medical Solutions Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2107-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-06 |
| Published | 2016-07-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | CA, CO, FL, IL, MO, ND, NE, NJ, NY, OH, PA, TX |
Product
SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.
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).
Identifiers
| code_info | Device Model # 10496180 Serial Numbers: 221176,130159,130773,100641,100642,100643,100644,100645,100811,100812,100813…Device Model # 10496180 Serial Numbers: 221176,130159,130773,100641,100642,100643,100644,100645,100811,100812,100813,100814,221129,130326,221192,130201,220930,130438,102113,130635,130377,130125,130546,130322,101309,101503,220743,102013,130575 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2107-2016%22
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