SYNGO Breast Care — Class II medical device recall Z-2107-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-07-06, distributed in CA, CO, FL, IL, MO, ND, NE, NJ…. Software issues. Siemens is voluntarily initiating a recall after they became aware of the following system be
| Recall number | Z-2107-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2016-06-06 |
| Classified | 2016-06-30 |
| Reported by FDA | 2016-07-06 |
| Terminated | 2017-01-17 |
| Distributed | CA, CO, FL, IL, MO, ND, NE, NJ, NY, OH, PA, TX |
| Quantity | 29 units |
| Reason classes | software |
| Serial numbers | 100641, 100642, 100643, 100644, 100645, 100811, 100812, 100813, 100814, 101309, 101503, 102013, 102113, 130125, 130159, 130201, 130322, 130326, 130377, 130438, 130546, 130575, 130635, 130773, 220743 and 4 more |
| Model numbers | 10496180 |
Product
SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2107-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.