Recall archive / FDA device enforcement
Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max — FDA record Z-1002-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 9, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 886 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1002-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jan 25, 2023
- Recall initiation date
- Dec 9, 2022
- Center classification date
- Jan 19, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.