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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There is a low potential likelihood for the pic 50 screen display to fail due to a partial or complete dislodging of the cable connecting the screen display to its circuit board. the potential for this failure mode may increase after severe impact to the device. this connection has passed relevant engineering standards and we are not aware of any defect in its design or manufacture.
Model Catalog: 971081E (Lot serial: MORE THAN 10 SERIAL NUMBERS.); Model Catalog: 971082E (Lot serial: MORE THAN 10 SERIAL NUMBERS.); Model Catalog: 971083E (Lot serial: MORE THAN 10 SERIAL NUMBERS.); Model Catalog: 971084E (Lot serial: MORE THAN 10 SERIAL NUMBERS.)