Use caution Medical device recall · FDA · Published December 9, 2021

Siemens ARTISTE Radiation Therapy Systems Recall: Risk of Wrong Treatment Site

Siemens recalls ARTISTE linear accelerator systems for cancer treatment due to potential risk of delivering radiation to the wrong body area, which could cause serious injury. Affected units have specific serial numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0441-2022Medical device Siemens ›

Use caution until it’s fixed

Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could result in serious patient injury

Take action

Contact the company

Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418

✎ GovInfoNow plain-language explainer

Siemens is recalling ARTISTE radiation therapy systems that could deliver radiation to the wrong body area during cancer treatment, risking serious injury. This recall affects specific models with listed serial numbers. Read more at govinfonow.com/recall/61441-siemens-artiste-radiation-therapy-systems-recall-risk-of-wrong-treatment.

Source Summary by GovInfoNow · govinfonow.com/recall/61441-siemens-artiste-radiation-therapy-systems-recall-risk-of-wrong-treatment · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0441-2022

Cite this page

“Siemens ARTISTE Radiation Therapy Systems Recall: Risk of Wrong Treatment Site.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61441-siemens-artiste-radiation-therapy-systems-recall-risk-of-wrong-treatment. Based on FDA recall #Z-0441-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0441-2022%22&limit=1).

The FDA announced on Dec. 9, 2021, that Siemens Medical Solutions USA, Inc. is recalling ARTISTE with syngo RT Therapist-linear accelerator systems due to a potential safety issue that may result in serious patient injury. The agency classified the recall as Class II.

How to tell if you have it

Brand: Siemens
Product: ARTISTE with syngo RT Therapist-linear accelerator systems
Model Number: 8162815
Serial Numbers: 10085, 10524, 10737, 10736, 10586, 10792, 10793, 10822, 10843, 10850, 10886, 10865, 11122
UDI: 040568691613655911
Quantity: 13 units

The hazard

The recall addresses a potential safety issue under specific preconditions that may result in a user selecting the wrong site for treatment. This error could lead to the delivery of dose to the wrong isocenter, which could result in serious patient injury.

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 the Siemens ARTIS icono Ceiling Monitor Recall (June 8, 2026), the Siemens ARTIS icono floor recall (May 20, 2026), and the Siemens ARTIS Pheno VE30A/VE40A recall (March 12, 2026). Other recent recalls of similar products include the Elekta Leksell GammaPlan 11.1 Software Recall (Dec. 12, 2025), the RayStation/RayPlan Software 11A Recalls (Nov. 28, 2025), and the Elekta Leksell GammaPlan software version 11.3/11.4 recall (Dec. 12, 2025).

How to tell if you have this one

Check if your ARTISTE system has serial numbers listed: 10085, 10524, 10737, 10736, 10586, 10792, 10793, 10822, 10843, 10850, 10886, 10865, 11122. The system is used for cancer radiation therapy.

Brand
Siemens
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check System Serial Number
Verify your ARTISTE system's serial number against the list: 10085, 10524, 10737, 10736, 10586, 10792, 10793, 10822, 10843, 10850, 10886, 10865, 11122.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 10 states.

FDA distribution: “US Nationwide distribution in the states of IA, LA, NE, NJ, NV, NY, OH, PA, SC, SD.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Iowa, Louisiana, Nebraska, Nevada, New Jersey, New York, Ohio, Pennsylvania, South Carolina, South Dakota.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

Dec 9, 2021Firm started the recall
Dec 29, 2021FDA classified it Class II
Jan 5, 2022Published in FDA’s Enforcement Report
May 4, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61441-siemens-artiste-radiation-therapy-systems-recall-risk-of-wrong-treatment">Siemens ARTISTE Radiation Therapy Systems Recall: Risk of Wrong Treatment Site (GovInfoNow)</a>

Where this comes from

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-0441-2022 (December 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0441-2022 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.