Drug recall
Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street…
FDA recall event 66744 · Class II · Carestream Health Inc.
Key facts
| Event ID | 66744 |
|---|---|
| Recall numbers | Z-0491-2014 |
| Recalling firm | Carestream Health Inc. |
| Product type | Devices |
| Products | Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolution Mobile system is a mobile diagnostic x-ray… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | It was discovered that Carestream received a report from a customer that 2 different patients were re-exposed due to the fact that the processed images were not able to be found in the system. |
| Initiation date | Aug 29, 2013 |
| Report date | Jan 15, 2014 |
| Termination date | Nov 18, 2015 |
| City | Rochester |
| State | NY |
| Country | United States |
| FEI number | 3006347606 |
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: