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 an incorrect orientation of the indicator dot on dental intraoral film packet labeling of some lots of insight item 811 0785 (size 0 packet) ib-01 and some lots of ultra-speed item 834 8658 (size 0 packet) df-48. the indicator dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the film. this issue may cause some confusion for the dental practitioner if the processed film is placed on the view box by referencing the film's raised dot. the result is the image orientation will be rotated 180 degrees. the remaining content on the label is correct. image quality is not affected by this issue.