Drug recall
Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and…
FDA recall event 88962 · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Event ID | 88962 |
|---|---|
| Recall numbers | Z-0296-2022, Z-0297-2022, Z-0298-2022, Z-0299-2022, Z-0300-2022, Z-0301-2022, Z-0302-2022, Z-0303-2022, Z-0304-2022, Z-0305-2022 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Product type | Devices |
| Products | Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848282, Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848281, Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848280, Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10848355, Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848354 and 5 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short… |
| Initiation date | Oct 20, 2021 |
| Report date | Dec 1, 2021 |
| Termination date | Jun 18, 2024 |
| City | Malvern |
| State | PA |
| Country | United States |
| FEI number | 2240869 |
At a glance
- 10–99 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: