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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If a user experiences a flashing low battery status indicator and does not understand that the device can continue to be used the user might choose not to continue operating the device causing therapy to be delayed or interrupted.
Model Catalog: 970308E (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 970302E (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 970311-E (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 970302F (Lot serial: MORE THAN 10 SERIAL NUMBERS)