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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Smiths medical became aware of an issue with the printed circuit board assembly ("pcba") supplied for use in level 1 fast flow fluid warmers h1200-en-115v-us. the pcba supplier ducommun reported having supplied incorrect pcba components which could cause the fluid warmer to not function as intended. this issue may result in false over temperature alarms.