Drug recall
SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital…
FDA recall event 74422 · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Event ID | 74422 |
|---|---|
| Recall numbers | Z-2107-2016 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Product type | Devices |
| Products | SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jun 6, 2016 |
| Report date | Jul 6, 2016 |
| Termination date | Jan 17, 2017 |
| City | Malvern |
| State | PA |
| Country | United States |
| FEI number | 2240869 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: