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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As a result of internal testing intuitive surgical has determined that the sterile barrier of the outer packaging for the vacuum source tubing set is subject to failure. some outer pouches exhibited pinholes during gross leak testing which could potentially result in compromising the sterile field.