Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max recallZ-1002-2023 · Siemens Medical Solutions USA, Inc · initiated Dec 9, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
A Customer Safety Advisory Notification (CSAN) was distributed to affected consignees beginning December 9, 2022. The CSAN was distributed to inform the customers about a preventative measure to exclude any potential risk of patient injury caused by the footrest detaching from the patient table during examination. Together with the CSAN, an addendum to the operator manual is distributed containing additional details and illustrations on how to securely attach the footrest to further improve the understanding of handling the footrest. Refer to the CSAN with addendum and copies of the Instructions for Use for each reported system.
Recall details
- Recall number
- Z-1002-2023
- Status
- Open, Classified
- Initiated by the company
- Dec 9, 2022
- Posted by the FDA
- Jan 20, 2023
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 886 units
- Product code
- OWB
- FDA submissions
- K173639
- Distribution
- Worldwide distribution
Product description
Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Luminos Agile Max 10762472Siemens Healthcare GmbH · System, x-ray, fluoroscopic, image-intensified3 recalls37 reports
- Luminos dRF Max 10762471Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system1 recall17 reports
Other devices under the same FDA submission
2 devices cleared under K173639 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- LUMINOS Lotus Max 11574100Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system2 recalls7 reports
- Multitom Rax 10860700Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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