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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It has been found that the sara 3000 sara plus minstrel and tenor devices have experienced problems with the electrical functions related to the printed circuit board (pcb) losing the safe working load (swl) settings resulting in the inconvenience of the device usage. arjohuntleigh has decided to perform a pcb software upgrade to eliminate the detected problem.