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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The internal mains wiring does not fully comply with the requirements of the medical electrical equipment standard iec60601-1 edition 3.0. iec60601-1 states that conductors and connectors of medical electrical equipment shall be secured or insulated so that accidental detachment shall not result in a hazardous situation. the k-mar-5200 mains wiring is secured but the mechanism is not considered suitable under the current version of iec60601-1.