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 stereo biopsy devices (serial numbers 2000 through 2090) for mammomat inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. the pin implemented in the safety switch may not put enough pressure on the safety circuit to prohibit movement. the needle positioning device may move even with the safety switch being set sideward. if this occurs with the needle being already inserted it could lead to an unintentional patient injury.