Drug recall
FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The…
FDA recall event 78644 · Class II · Fujifilm Medical Systems U.S.A., Inc.
Key facts
| Event ID | 78644 |
|---|---|
| Recall numbers | Z-0232-2018 |
| Recalling firm | Fujifilm Medical Systems U.S.A., Inc. |
| Product type | Devices |
| Products | FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to generate digital or conventional radiographic images of… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the Digital Radiography System FDR Visionary Suite. The X-ray tube assembly in these devices is mounted to a tube mounting… |
| Initiation date | Jun 15, 2017 |
| Report date | Dec 20, 2017 |
| Termination date | May 9, 2018 |
| City | Stamford |
| State | CT |
| Country | United States |
| FEI number | 2443168 |
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: