Drug recall
Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with…
FDA recall event 75834 · Class II · Shimadzu Medical Systems
Key facts
| Event ID | 75834 |
|---|---|
| Recall numbers | Z-0918-2017 |
| Recalling firm | Shimadzu Medical Systems |
| Product type | Devices |
| Products | Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube Diagnostic x-ray high voltage generator. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generator due to the possibility of oil leaking from the x-ray tube housing under certain conditions. |
| Initiation date | Nov 20, 2016 |
| Report date | Jan 4, 2017 |
| Termination date | Dec 11, 2017 |
| 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: