Drug recall
ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product Usage: Artis is a family of…
FDA recall event 80586 · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Event ID | 80586 |
|---|---|
| Recall numbers | Z-2747-2018, Z-2748-2018 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Product type | Devices |
| Products | ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and…, Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of dedicated angiography systems developed for single and… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential hardware issue which may cause thermal effects and possible damage to system parts. |
| Initiation date | Jun 22, 2018 |
| Report date | Aug 22, 2018 |
| Termination date | Jan 15, 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: