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 design of the ultralite mark ii model relies on the cable adapter that is is assembled through the headlight body top into the lens cell top to hold the headlight in place and prevent the headlight from falling off. if the cable adapter becomes loose there is a potential that the headlight assembly can become separated from the headband assembly and drop into the patient wound site.
Model Catalog: (Lot serial: AX2100BIF); Model Catalog: (Lot serial: AX2000BIF); Model Catalog: (Lot serial: AX1375BIF); Model Catalog: (Lot serial: AX1385BIF); Model Catalog: (Lot serial: 001380LX); Model Catalog: (Lot serial: 001328)