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 | Examination room monitor connected with the hybrid cable may have a display issue and no image function is available |
| Product | ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10848600 |
| Quantity | 4 units US |
| Distribution | Worldwide - US Nationwide distribution in the states of FL, SD, PR and the countries of Angola, Argentina, Australia, Brazil, Bulgaria, China, Georgia, Germany, India, Indonesia, Iraq, Japan, Malaysia, Morocco, Nepal, Nigeria, Poland, Russia, Rwanda, Serbia, Slovenia, South Africa, Spain, Sudan, Syria, Taiwan, Thailand, Uganda, Ukraine, United Kingdom, Uzbekistan, Vietnam. |
| Initiated | 2023-03-21 |
| Classified | 2023-04-27 |
| Recall number | Z-1469-2023 |
| 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-1469-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92118/
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