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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When performing an sphb measurement in cold conditions the pronto-7 rainbow reusable sensor may incorrectly measure actual finger temperature. as a result pronto-7 spot check pulse co-oximeter may provide an incorrect sphb measurement.
Model Catalog: 2953 (Lot serial: All serial #s from A83F90 & up); Model Catalog: 2952 (Lot serial: All serial #s from A83F90 & up); Model Catalog: 2920 (Lot serial: All serial #s from A83F90 & up); Model Catalog: 9147 (Lot serial: All serial #s from A83F90 & up); Model Catalog: 2954 (Lot serial: All serial #s from A83F90 & up); Model Catalog: 2951 (Lot serial: All serial #s from A83F90 & up)