Health Canada — Medical Devices · Canada · 2015-04-30 · Type III
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Reported risk: Images might be lost and corresponding acquisitions have to be repeated under the following circumstances: -during an image recovery process on systems with portable detectors (Max WI-D, Max Mini) the connection of the portable detector is sporadically not re-established. -if either the "undo" button on the rad subtask card or the "previous series" button on the image subtask card are pressed during image readout. -sporadically, during an automatic or a manual RIS update. This may cause the deletion of the currently used study and all acquired images within this study.
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