Drug recall
ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
FDA recall event 80417 · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Event ID | 80417 |
|---|---|
| Recall numbers | Z-2524-2018 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Product type | Devices |
| Products | ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system control to… |
| Initiation date | May 30, 2018 |
| Report date | Aug 1, 2018 |
| Termination date | Feb 14, 2020 |
| City | Malvern |
| State | PA |
| Country | United States |
| FEI number | 2240869 |
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: