Drug recall
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and…
FDA recall event 97135 · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Event ID | 97135 |
|---|---|
| Recall numbers | Z-2019-2025, Z-2020-2025, Z-2021-2025, Z-2022-2025 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Product type | Devices |
| Products | ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients…, interventional fluoroscopic x-ray system |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA Requested |
| Reason for recall | In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an… |
| Initiation date | May 15, 2025 |
| Report date | Jul 9, 2025 |
| 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: