Drug recall
Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific…
FDA recall event 64684 · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Event ID | 64684 |
|---|---|
| Recall numbers | Z-0992-2013 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Product type | Devices |
| Products | Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiographic x-ray system |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | In the course of the firm's product monitoring activities, a potential risk for patient or operators was determined during the operation of an Artis zeego system with software revision VC14, VC20 and… |
| Initiation date | Nov 26, 2012 |
| Report date | Apr 3, 2013 |
| Termination date | Dec 24, 2013 |
| 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: