Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Carestream has identified that in the case of a control system failure the dr 9000 u-arm may move downward unexpectedly when the radiology technologist is positioning the equipment using the "up" or "down" device control buttons. this downward movement occurs at three times the normal rate of speed and will continue until the device control button is released the emergency stop button is activated or the equipment bump sensor contacts an object. there is a potential for injury if this issue occurs for patients positioned under the u-arm for decubitus exams.