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.
Reason for recall: 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. Distribution: Worldwide distribution Quantity: 886 units Lot/code info: 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
4056869009162, 4056869009155, 4056869269331
Official record: FDA (Device enforcement) ↗
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