Drug recall
DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main…
FDA recall event 67047 · Class II · Carestream Health, Inc.
Key facts
| Event ID | 67047 |
|---|---|
| Recall numbers | Z-0796-2014, Z-0797-2014, Z-0798-2014 |
| Recalling firm | Carestream Health, Inc. |
| Product type | Devices |
| Products | DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a…, DRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a…, DRX-Evolution with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement. |
| Initiation date | Nov 25, 2013 |
| Report date | Jan 29, 2014 |
| Termination date | Jun 30, 2016 |
| City | Rochester |
| State | NY |
| Country | United States |
| FEI number | 1317307 |
At a glance
- 1–9 Products in this recall
- 1–9 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: