Drug recall
Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general…
FDA recall event 64803 · Class II · Shimadzu Medical Systems
Key facts
| Event ID | 64803 |
|---|---|
| Recall numbers | Z-1369-2013 |
| Recalling firm | Shimadzu Medical Systems |
| Product type | Devices |
| Products | Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of out patients in emergency . |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The recall was initiated because Shimadzu Corporation has identified a potential issue in certain manufacturing lots of the Shimadzu MobileDaRt Evolution in combination with CXDI-70C, CXDI-55C, and… |
| Initiation date | Mar 18, 2013 |
| Report date | Jun 12, 2013 |
| Termination date | Feb 13, 2014 |
| City | Torrance |
| State | CA |
| Country | United States |
| FEI number | 1000125362 |
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: