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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Specific cdi blood parameter monitoring system 500 devices are being voluntarily recalled because the bpm sensor head assembly's thermistor which provides the blood temperature value that results in accurate display values on the monitor does not meet specification. this may cause inaccurate temperature measurement and inaccurate analyte display values on the cdi system 500 monitor. terumo cardiovascular systems (ryan medical distributors inc.) received complaints of inaccurate temperature measurements for specific devices distributed since november 5 2015. these include both new production devices and recently serviced devices.