Drug recall
Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee…
FDA recall event 88412 · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Event ID | 88412 |
|---|---|
| Recall numbers | Z-2404-2021 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Product type | Devices |
| Products | Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/ restart, and result in delay of clinical treatment |
| Initiation date | Jun 30, 2021 |
| Report date | Sep 8, 2021 |
| Termination date | Feb 10, 2023 |
| 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: