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 | Ongoing |
| Reason | A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video signals. This issue can sporadically affect the Large Display in the examination room as well as the displays in the control room. |
| Product | Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000 |
| Quantity | 136 systems |
| Distribution | Domestic distribution nationwide. Foreign distribution to Australia Austria Belgium Brazil Canada China Colombia Denmark Finland France Germany Hungary Indonesia Iran Italy Japan Kuwait Mexico Monaco Netherlands Norway Poland Singapore Slovakia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom United States Vietnam |
| Initiated | 2022-06-10 |
| Classified | 2022-06-27 |
| Recall number | Z-1294-2022 |
| 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-1294-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90507/
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