Use cautionMedical device recall · FDA · Published September 20, 2022
Siemens ARTIS pheno X-ray System Recall: Software Issues May Cause Treatment Delays
Siemens recalls ARTIS pheno interventional fluoroscopy systems with software version VE10B due to potential treatment delays. Affected units may require switching to another system if procedures cannot continue.
Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.
Take action
Contact the company
📍Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418
“Siemens ARTIS pheno X-ray System Recall: Software Issues May Cause Treatment Delays.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/60041-siemens-artis-pheno-x-ray-system-recall-software-issues-may. Based on FDA recall #Z-0119-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0119-2023%22&limit=1).
The FDA announced on Sept. 20, 2022, that Siemens Medical Solutions USA, Inc. is recalling ARTIS pheno interventional fluoroscopic x-ray systems due to potential software issues. These defects may prevent treatment continuation on the affected system. Owners should contact Siemens for a remedy.
How to tell if you have it
Brand: Siemens
Product: ARTIS pheno, Interventional fluoroscopic x-ray system
Model No.: 10849000
Software version: VE10B
Units affected: 140 in the U.S.
The hazard
Siemens identified three potential software issues with ARTIS pheno systems running software version VE10B. These issues may lead to a hazardous situation for patients if treatment cannot be continued on the system and must be transferred to an alternate one.
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), Philips Achieva 3.0T MRI Recalled (Aug. 21, 2026), and Canon Alphenix INFX-8000F X-Ray System Recall (Dec. 19, 2025).
How to tell if you have this one
Check for the model number 10849000 and software version VE10B. Affected units have specific serial numbers listed in the recall notice.
Brand
Siemens
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on the system; affected units have version VE10B.
Contact Siemens
Reach out to Siemens for guidance on whether your system needs to be updated or replaced.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Domestic distribution nationwide. Foreign distribution worldwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 43 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-0119-2023 (September 20, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0119-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.