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Siemens Medical Solutions USA, Inc Recall 91383

Description: Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max

Siemens Medical Solutions USA, Inc Recall 91383 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1002-2023
Event ID91383
Event DescriptionLuminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
Product TypeDevices
DistributionWorldwide distribution
Quantity886 units
Recall ReasonThere 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.
Device Classification20230125
Device Code InfoAll 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
Center Classification Date20230119
Recall Initiation Date20221209
Recalling FirmSiemens Medical Solutions USA, Inc
Initial Notification Letter
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