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 | Due to improper soldering in a limited number of large display bypass module components of a specific production lot, a loss of video signal could potentially occur. This has not been observed in the field and only sporadic cases have been observed in factory screening. |
| Product | Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures. |
| Quantity | 17 |
| Distribution | US Distribution to the states of : IL, WI, MA, FL, AL, TN, ND, OH, TX, CA, NJ and MI. |
| Initiated | 2015-10-30 |
| Classified | 2015-12-24 |
| Terminated | 2017-03-28 |
| Recall number | Z-0481-2016 |
| 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-0481-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72742/
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