Use caution Medical device recall · FDA · Published December 9, 2022

Siemens Luminos Max Models Recall: Footrest Detachment Risk

Siemens recalls Luminos Agile Max, dRF Max, and Lotus Max models due to potential footrest detachment during use, which could cause injury. Affected units have specific serial numbers and are used in medical imaging.

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

🇺🇸 FDA recall #Z-1002-2023Medical device Siemens ›

Use caution until it’s fixed

There is potential for the footrest to detach from the patient table during use. Device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients. These devices are not for mammography examinations.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Siemens is recalling three medical imaging systems (Luminos Agile Max, dRF Max, and Lotus Max) because the footrest might detach from the patient table during use. This could lead to injury if the patient or equipment is not properly secured. Read more at govinfonow.com/recall/59175-siemens-luminos-max-models-recall-footrest-detachment-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/59175-siemens-luminos-max-models-recall-footrest-detachment-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1002-2023

Cite this page

“Siemens Luminos Max Models Recall: Footrest Detachment Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59175-siemens-luminos-max-models-recall-footrest-detachment-risk. Based on FDA recall #Z-1002-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1002-2023%22&limit=1).

The FDA announced on Dec. 9, 2022, that Siemens Medical Solutions USA, Inc. is recalling Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max imaging systems due to the potential for footrests to detach during use. The agency issued recall number Z-1002-2023 for the Class II voluntary recall.

How to tell if you have it

Luminos Agile Max, Material #10762472, UDI/DI: 4056869009162
Luminos drF Max, Material #10762471, UDI/DI: 4056869009155
Luminos Lotus Max, Material #11574100, UDI/DI: 4056869269331

The hazard

The hazard involves the potential for the footrest to detach from the patient table during use. The devices are intended to visualize anatomical structures by converting an X-ray pattern into a visible image and may be used on pediatric, adult, and bariatric patients.

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 IMRIS ORT300 Operating Room Table Recall (Aug. 6, 2026) and the Philips Azurion 7 B20 System Recall (Jan. 26, 2026).

How to tell if you have this one

Check for the specific model names: Luminos Agile Max, dRF Max, or Lotus Max. Look for the serial numbers listed: 10762472, 10762471, or 11574100.

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
Worldwide distribution

Recall number	Product, codes & lots	Quantity
Z-1000-2023	AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF; All serial numbers 1) AXIOM Luminos TF, Material #10093902 (no UDI) 2) AXIOM Iconos R100, Material #05895151 (no UDI) 3) AXIOM Iconos R200 C69, Material #10093961 (no UDI) 4) AXIOM Iconos R200 C20, Material #10093962 (no UDI) 5) AXIOM Luminos dRF, Material #10094200 (no UDI)	654 units
Z-1001-2023	AXIOM Luminos Agile; All serial numbers for AXIOM Luminos Agile, Material #10502200 (no UDI)	271 units
Z-1002-2023	Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max; All serial numbers 1) Luminos Agile Max, Material #10762472, UDI/DI: 4056869009162 2) Luminos drF Max, Material #10762471, UDI/DI: 4056869009155 3) Luminos Lotus Max, Material #11574100, UDI/DI: 4056869269331	886 units

Based on the official FDA remedy

What to do — step by step

Check Model and Serial Numbers
Identify the model name and serial number from the device's label to confirm if it is affected.

How this recall unfolded

Recall timeline

FDA published this recall 47 days after the firm started it.

Dec 9, 2022Firm started the recall
Jan 19, 2023FDA classified it Class II
Jan 25, 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/59175-siemens-luminos-max-models-recall-footrest-detachment-risk">Siemens Luminos Max Models Recall: Footrest Detachment Risk (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-1002-2023 (December 9, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1002-2023 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.