Class II — Siemens Medical Solutions USA, Inc
| Recalling firm | SIEMENS MEDICAL SOLUTIONS USA, INC. |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Artis zee/Q systems patient tables may potentially have cracks in the table mainframe, and cause mechanical detachment of the upper part of the patient bed and lead to hazardous situations for patients and medical personnel due to falling parts |
| Product | Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems Material Number Artis zee biplane 10094141; Artis Q floor 10848280; Artis Q biplane 10848282; Artis Q.zen floor 10848353; Artis Q.zen biplane 10848355; Artis zee ceiling 10094137; Artis Q ceiling 10848281; Artis Q zeego 10848283 ArtisQ.zen ceiling 10848354 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional proc… |
| Quantity | US 17 |
| Distribution | US Nationwide Distribution - AL, AR, KS, MI, MN, NC, ND, NY, OH, SC, TX, WI |
| Initiated | 2019-07-30 |
| Classified | 2019-08-24 |
| Terminated | 2020-04-29 |
| Recall number | Z-2367-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Medical Solutions USA, Inc (Z-2367-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83565/
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