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 firm distributed a field correction letter notifying users to check that the audio function is working each time they use the device with a label for each unit and new updated dfus.
Model Catalog: 53S00-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53N00-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53N00-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53N0P-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53S0P-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53S0P-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53S00-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53N0P-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NTP-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 530TP-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53STP-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 530TP-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NTP-E1R (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53STP-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NTP-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53ST0-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NT0-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NT0-F1 (Lot serial: