Drug recall
MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams…
FDA recall event 85719 · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Event ID | 85719 |
|---|---|
| Recall numbers | Z-2388-2020 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Product type | Devices |
| Products | MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum biopsy system is being used, the tube arm's manual movement range is decreased from +/-15 deg. to +/- 6… |
| Initiation date | May 7, 2020 |
| Report date | Jun 24, 2020 |
| Termination date | Sep 29, 2022 |
| 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: