Use cautionMedical device recall · FDA · Published May 27, 2021
Siemens ARTIS pheno angiography systems recall: Software error may cause C-arm to move out
Siemens recalls ARTIS pheno angiography systems with software VE10B error that could cause C-arm to deviate up to 22 cm during imaging procedures, risking treatment interruption.
Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging (PERISTEPPING/PERIVISION), the C-arm may leave its intended travel path by up to 22 cm (9") result in canceling clinical treatment or to continue treatment on an alternative system
Take action
Contact the company
📍Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355
“Siemens ARTIS pheno angiography systems recall: Software error may cause C-arm to move out.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62466-siemens-artis-pheno-angiography-systems-recall-software-error-may-cause. Based on FDA recall #Z-2029-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2029-2021%22&limit=1).
The FDA announced on May 27, 2021, that Siemens Medical Solutions USA, Inc. is recalling ARTIS pheno angiography systems due to a software error that may cause the C-arm to leave its intended travel path. The recall affects 116 units distributed nationwide.
According to the FDA, a software error in version VE10B may cause the C-arm to leave its intended travel path by up to 22 cm (9 inches) during stepped peripheral imaging. This fault can result in canceling clinical treatment or requiring treatment on an alternative system.
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 GE Optima XR200amx Mobile Radiography System Recall (June 5, 2026), Elekta Leksell Vantage Arc System Recall (March 19, 2026), and Philips Azurion System Software R3.1 May Cause Imaging Loss - Recall (December 12, 2025).
How to tell if you have this one
Check if your system has serial numbers listed in the provided list (e.g., 164138, 164159) or software version VE10B. The systems are used for single and biplane diagnostic imaging and interventional procedures.
Brand
Siemens
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check System Serial Number
Verify your system's serial number against the list of affected serial numbers provided in the recall notice.
Contact Siemens for Guidance
Reach out to Siemens Medical Solutions USA, Inc. for specific instructions on whether your system requires correction or alternative action.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 48 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-2029-2021 (May 27, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2029-2021 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.