Use cautionMedical device recall · FDA · Published November 9, 2022
Siemens ARTISTE/ONCOR/PRIMUS Radiation Therapy Software Version 4.3.1 MR3 Recall: Wrong
Siemens recalls ARTISTE, ONCOR and PRIMUS radiation therapy systems with software version 4.3.1 MR3 due to risk of delivering radiation to the wrong body site during cancer treatment. Affected units have specific serial numbers and material numbers.
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
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Contact the company
📍Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418
✎ GovInfoNow plain-language explainer
Siemens is recalling ARTISTE, ONCOR, and PRIMUS radiation therapy systems with software version 4.3.1 MR3. This software version may cause the system to select the wrong treatment site, potentially delivering radiation to the incorrect body area during cancer treatment. Read more at govinfonow.com/recall/59444-siemens-artiste-oncor-primus-radiation-therapy-software-version-4-3.
“Siemens ARTISTE/ONCOR/PRIMUS Radiation Therapy Software Version 4.3.1 MR3 Recall: Wrong.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59444-siemens-artiste-oncor-primus-radiation-therapy-software-version-4-3. Based on FDA recall #Z-0472-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0472-2023%22&limit=1).
The FDA announced on November 9, 2022, that Siemens Medical Solutions USA, Inc. is recalling ARTISTE, ONCOR and PRIMUS linear accelerator systems with syngo RT Therapist software version 4.3.1 MR3 due to a hazard involving potential delivery of radiation doses to the wrong isocenter.
How to tell if you have it
Brand: Siemens
Product: ARTISTE, ONCOR and PRIMUS with syngo RT Therapist
Software version: 4.3.1 MR3
Material Number: 8162815
Serial Numbers: 10736, 10737, 10822, 10850, 10886, 10843, 10865, 10025
The hazard
According to the FDA, when selecting the site fraction group for treatment, users may select the wrong site for treatment and potentially deliver the dose to the wrong isocenter.
Context
GovInfoNow's records show Siemens Medical Solutions USA, Inc. has 182 other recalls on record since June 6, 2017. Other recent recalls of similar products include Siemens ARTIS icono Ceiling Monitor Recall (June 8, 2026), Siemens ARTIS Icono Biplane Recall (May 20, 2026) and Siemens ARTIS Pheno VE30A/VE40A Recall (March 12, 2026). Other recent recalls of similar products include Elekta MOSAIQ Oncology System Software Recall (May 21, 2026), Elekta Leksell GammaPlan 11.1 Software Recall (December 12, 2025) and RayStation 2024B Software Recall (November 28, 2025).
How to tell if you have this one
Check for serial numbers 10736, 10737, 10822, 10850, 10886, 10843, 10865, or 10025 on the system. The software version must be 4.3.1 MR3 with material number 8162815.
Brand
Siemens
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version is 4.3.1 MR3 and the material number is 8162815.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CA, IA, LA, NE, NV, OH, SC.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Iowa, Louisiana, Nebraska, Nevada, Ohio, South Carolina.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0472-2023 (November 9, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0472-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.