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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Possibility that choice of patient will be changed when using filtered work lists. normally problem detected because the "active" name of patient is displayed. this affects pcr eleva system connected to a ris.
Model Catalog: PCR ELEVA PLUS (Lot serial: N/A); Model Catalog: PCR ELEVA S (Lot serial: N/A); Model Catalog: MCR1511 (Lot serial: N/A); Model Catalog: PCR ELEVA S PLUS (Lot serial: N/A); Model Catalog: PCR ELEVA CORADO (Lot serial: N/A)