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Siemens Medical Solutions USA, Inc recalls Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max

Recalled January 25, 2023 · FDA recall Z-1002-2023 · Siemens Medical Solutions USA

Hazard
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 Class II
Units
886 units
Sold at
Worldwide distribution

Description

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.

Product
Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
Manufacturer(s)
Siemens Medical Solutions USA, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Siemens Medical Solutions USA, Inc recalls Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max | RecallWatchUSA