Lower riskMedical device recall · FDA · Published November 23, 2022
Siemens Luminos Agile Max Fluoroscopy System May Show Incorrect Air Kerma Rate
Siemens recalls Luminos Agile Max (VE10, VF10, VF1:1) fluoroscopy systems that may display incorrect air kerma rates during exams. No impact on diagnosis or workflow, but potential for rare errors in specific systems.
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube. Siemens Healthineers became aware of one customer site where this issue was identified during clinical operation.
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Contact the company
📍Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418
“Siemens Luminos Agile Max Fluoroscopy System May Show Incorrect Air Kerma Rate.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59287-siemens-luminos-agile-max-fluoroscopy-system-may-show-incorrect-air. Based on FDA recall #Z-1479-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1479-2023%22&limit=1).
The FDA announced on November 23, 2022, that Siemens Medical Solutions USA, Inc. is recalling Luminos Agile Max imaging systems due to potential incorrect air kerma displays during fluoroscopic examinations. The agency issued the Class II recall under number Z-1479-2023.
How to tell if you have it
Brand: Siemens
Product: Luminos Agile Max (VE10, VF10, VF11)
Model: 10762472
Units affected: 704 in the United States
The hazard
According to IEC 60601-2-43, the Fluorospot Compact might sporadically display incorrect air kerma or air kerma rate related to the patient reference point during fluoroscopic examinations. This error occurs only in systems with a second overhead X-ray tube and has no impact on workflow or diagnosis. Siemens Healthineers identified one customer site where this issue occurred during clinical operation.
Context
GovInfoNow's records show Siemens Medical Solutions USA, Inc. has 182 other recalls on record since June 6, 2017. Recent similar recalls include the Siemens ARTIS icono Ceiling Monitor Recall regarding loose screws (June 8, 2026), the Siemens ARTIS icono ceiling recall for loss of movement after extreme height adjustments (May 20, 2026), and the Siemens ARTIS Pheno VE30A/VE40A recall for inaccurate 3D scans due to radiation exposure (March 12, 2026). Other recent recalls of similar products include the AGFA DR 800 X-Ray System Recall regarding the risk of exceeding air kerma limits (November 18, 2025).
How to tell if you have this one
Check for model numbers VE10, VF10, or VF11 on the Luminos Agile Max system. The recall applies to systems sold with the model number 10762472.
Brand
Siemens
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide - Worldwide Distribution
Recall number
Product, codes & lots
Z-1479-2023
Luminos Agile Max (VE10, VF10, VF11); Model: 10762472
Z-1480-2023
Luminos dRF Max (VE10, VF10, VF11); Model: 10762471
Z-1481-2023
LUMINOS Lotus Max (VF11); Model: 11574100
Based on the official FDA remedy
What to do — step by step
Check System Model
Identify the model number on your Luminos Agile Max system to confirm if it is VE10, VF10, or VF11.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “US Nationwide - Worldwide 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 6 months 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-1479-2023 (November 23, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1479-2023 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.