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Siemens Medical Solutions USA, Inc recalls SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film casse
Recalled June 3, 2015 · FDA recall Z-1669-2015 · Siemens Medical Solutions USA
Hazard
Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing undo button on the RAD subtask card or previous series button on the Image subtask card during image readout. Sporadically, during an automatic or a manual RIS update. · FDA Class II
Units
133 total
Sold at
Nationwide Distribution.
Description
Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing undo button on the RAD subtask card or previous series button on the Image subtask card during image readout. Sporadically, during an automatic or a manual RIS update.
Product
SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is applicable to emergency treatment on an outpatient basis, as well as for bedside examinations.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →