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 | Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy. |
| Product | ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13 |
| Quantity | 1012 |
| Distribution | Worldwide distribution. US consignees in the following states: Alabama, California, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia… |
| Initiated | 2020-02-18 |
| Classified | 2020-04-07 |
| Terminated | 2021-02-09 |
| Recall number | Z-1677-2020 |
| 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-1677-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85161/
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