X-ray imaging system footrests may detach from patient tables
Siemens Luminos X-ray imaging systems may have a footrest that detaches from the patient table during use. The manufacturer is recalling 886 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a risk-of-harm product—potential footrest detachment during patient examination—with no injuries reported to date. The potential for patient harm during medical imaging procedures justifies a High severity rating per the rubric.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling three models of Luminos diagnostic X-ray imaging systems: Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max. The footrest on the patient table in these systems may detach during use, which may cause patient injury.
These systems are designed to visualize anatomical structures by converting X-ray patterns into visible images. They are used for a wide range of clinical applications including gastrointestinal, cranial, skeletal, thoracic, lung, and urogenital examinations, as well as emergency applications, interventional radiology, and specialized imaging procedures. The systems can accommodate pediatric, adult, and bariatric patients.
The recall affects 886 units distributed worldwide. Patients using affected systems should consult their healthcare provider or the facility operating the equipment. Healthcare facilities should verify whether they own affected equipment by checking the model and serial numbers and contact the manufacturer for repair or replacement instructions.
The recalled product
- Product
- Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- footrest-detachment
- fall-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 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
Distribution
Distribution scope not specified by the agency.
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