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 | When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter |
| Product | ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. |
| Quantity | 8 units US |
| Distribution | US Nationwide distribution in the states of CA, IA, LA, NE, NV, OH, SC. |
| Initiated | 2022-11-09 |
| Classified | 2022-12-09 |
| Recall number | Z-0472-2023 |
| 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-0472-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91182/
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