Use caution Medical device recall · FDA · Published February 2, 2023

Siemens ARTIS pheno Systems: C-arm inaccuracy risk during angiography procedures

Siemens recalls ARTIS pheno angiography systems with specific table models due to potential 5-10mm C-arm positioning error during procedures, risking patient or staff injury.

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

🇺🇸 FDA recall #Z-1498-2023Medical device Siemens ›

Use caution until it’s fixed

If, during the procedure, X-ray has been released and a reference image has been stored, the following issue may occur: If "Adjust C-arm to Ref" is activated when the C-Arm is positioned outside of the working range the C-Arm will reach the target position with an inaccuracy of 5-10 mm. As a result, the message Endposition reached will be displayed .Leading to unintended direction of the movement causing crushing of a patient, staff member, operator, or equipmen Live images may not match the previously stored reference images. Overlay images may be shown inaccurate on anatomy (e.g., DSA Roadmap workflow does not match real anatomy). This may cause e.g., a vessel perforation in DSA roadmap.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Siemens is recalling certain ARTIS pheno angiography systems that may cause the C-arm to move inaccurately by 5-10mm during procedures, potentially crushing patients or staff. This could also lead to inaccurate imaging and vessel perforations. Read more at govinfonow.com/recall/58966-siemens-artis-pheno-systems-c-arm-inaccuracy-risk-during-angiography.

Source Summary by GovInfoNow · govinfonow.com/recall/58966-siemens-artis-pheno-systems-c-arm-inaccuracy-risk-during-angiography · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1498-2023

Cite this page

“Siemens ARTIS pheno Systems: C-arm inaccuracy risk during angiography procedures.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58966-siemens-artis-pheno-systems-c-arm-inaccuracy-risk-during-angiography. Based on FDA recall #Z-1498-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1498-2023%22&limit=1).

The FDA announced on Feb. 2, 2023, that Siemens Medical Solutions USA, Inc. is recalling ARTIS pheno angiography systems due to potential patient injury from inaccurate C-arm positioning. The agency issued recall number Z-1498-2023 for the Class II device.

How to tell if you have it

Brand: Siemens
Product: ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)
Model: 10849000
UDI: 04056869046877
Serial numbers: 164140, 164159, 164138, 164332, 164331, 164033, 164287, 164282, 164210, 164184, 164183, 164311, 164142, 164312, 164071, 164328, 164034, 164391, 164318, 164244, 164306, 164155, 164340, 164189, 164277, 164173, 164292, 164231, 164095, 164057, 164055, 164054, 164329, 164072, 164190, 164048, 164025, 164026, 164027, 164338, 164094, 164241, 164326, 164267, 164186, 164068, 164121, 164157, 164019, 164152, 164161, 164013, 164069, 164213, 164073, 164293, 164263, 164298, 164060, 164083, 164113, 164021, 164066, 164398, 164362, 164124, 164125, 164366, 164279, 164075, 164098, 164028, 164153, 164330, 164389, 164394, 164172, 164086, 164084, 164074, 164295, 164353, 164234, 164321, 164242, 164275, 164270, 164315, 164344, 164163, 164158, 164053, 164171, 164297, 164134, 164253, 164333, 164188, 164377, 164403, 164063, 164064, 164397, 164300, 164299, 164105, 164160, 164024, 164080, 164049, 164240, 164359, 164227, 164228, 164018, 164022, 164250, 164061, 164187, 164115, 164399, 164011, 164211, 164216, 164204, 164205, 164212, 164100, 164097, 164269, 164303, 164322, 164355, 164400, 164196, 164352, 164168, 164319, 164201, 164202, 164371
Units affected: 141

The hazard

GovInfoNow's records show that if the C-Arm is positioned outside its working range when "Adjust C-arm to Ref" is activated, it may reach the target with a 5-10 mm inaccuracy. This can cause unintended movement leading to crushing of patients or staff, and inaccurate overlay images that may result in vessel perforation during DSA roadmap procedures.

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 GE Optima XR200amx Mobile Radiography System Recall (June 5, 2026) and the Elekta Leksell Vantage Arc System Recall (March 19, 2026).

How to tell if you have this one

Check for the model number 10849000 on the system, or serial numbers starting with 164000-164400. The system includes either a Siemens Healthineers table or a Trumpf/MAQUET table (OEM).

Brand
Siemens
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check System Model
Verify the system model number is 10849000 and the serial number starts with 164000-164400.
Contact Manufacturer
Reach out to Siemens Medical Solutions USA, Inc. for further assistance with the recall.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide - US Nationwide distribution.” 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 3 months after the firm started it.

Feb 2, 2023Firm started the recall
May 2, 2023FDA classified it Class II
May 10, 2023Published in FDA’s Enforcement Report

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/58966-siemens-artis-pheno-systems-c-arm-inaccuracy-risk-during-angiography">Siemens ARTIS pheno Systems: C-arm inaccuracy risk during angiography procedures (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-1498-2023 (February 2, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1498-2023 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.