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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Areas of current design are not compliant with iec-60601-1. if headphone jack is in use during a surgical procedure with the ocs2 and a non-intended voltage comes in contact with outer case of unit voltage could be transmitted to patient.