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 | Suboptimal routing of the cable may result in increased wear over time. Without additional measures, damage of a cable may result in limited functionality and in rare cases, failure of a system. An ongoing procedure could be terminated in rare cases. |
| Product | Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: The Artis family is dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. |
| Quantity | 50 |
| Distribution | Nationwide Distribution |
| Initiated | 2014-12-03 |
| Classified | 2015-01-14 |
| Terminated | 2015-04-06 |
| Recall number | Z-0972-2015 |
| 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-0972-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70016/
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