Reported Jan 25, 2023 · Ongoing
Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
- Lot codes and dates
All serial numbers 1) Luminos Agile MaxMaterial #10762472
- UDI/DI
4056869009162 2) Luminos drF MaxMaterial #10762471
- UDI/DI
4056869009155 3) Luminos Lotus MaxMaterial #11574100
- UDI/DI4056869269331
- Amount recalled
- 886 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
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.
This product could cause temporary or reversible health problems — stop using it.
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