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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An addendum to the instructions for use is being provided for somatom force systems with software version va50a to inform users about a potential malfunction for turbo flash scans with very short scan ranges. when selecting the turbo flash mode in combination with a spiral scan length of less than 27 mm the image reconstruction will possibly fail for this scan. as a work around the addendum suggests for the turbo flash mode to always select a spiral scan length higher than 27 mm or to switch to another mode instead.