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 | After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, the system cannot be operated normally. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system. |
| Product | Artis zee floor MN, Material no. 10094142, for angiography and whole body radiographic/fluoroscopic procedures. |
| Quantity | 1 |
| Distribution | Worldwide distribution. US nationwide including Puerto Rico, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Luxembourg, Mexico, Myanmar, Netherlands, New Zealand, Norway, China, Paraguay, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, So… |
| Initiated | 2018-05-01 |
| Classified | 2018-06-27 |
| Terminated | 2019-05-16 |
| Recall number | Z-2312-2018 |
| 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-2312-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80286/
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