Drug recall
Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
FDA recall event 65487 · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Event ID | 65487 |
|---|---|
| Recall numbers | Z-1694-2013 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Product type | Devices |
| Products | Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Firm became aware of an unintended behavior when using the Mammomat Inspiration. The possibility exists that a malfunction may occur during Stereo or Tomo acquisitions if the tomo clutch was… |
| Initiation date | Feb 28, 2013 |
| Report date | Jul 17, 2013 |
| Termination date | Feb 21, 2014 |
| 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: