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 combination of the test tube heater (k-fth-1012) and power supply (k-aps-300) was recently re-tested for a proposed design change and found to exceed the limits for radiated emissions and is therefore no longer compliant with iec60601-1-2: 2007 (medical electrical equipment - part 1-2 basic safety and essential performance - collateral standard). the radiated rf emissions of the k-aps-300 power supply exceed the limits given in cispr11 group 1 class b by up to 6.3dbuv/m at three metres with very broad peaks occurring at about 85 90mhz and 150mhz.