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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Atricure has become aware of complaints regarding the acm1 related to customer satisfaction / user annoyance. specifically a high temperature error (exceeding 40 c) which results in a p2 error. the p2 error is a hard fault which requires the acm unit to be manually reset per the user manual. there is no risk to the patient as a result of the system shutdown.