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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Manufacturer has identified a sequence of events which may delay establishment of new conductivity alarm limits when the sodium level is adjusted upwards.
Model Catalog: STS1000-L3PDP (Lot serial: S/N 23764 AND BELOW); Model Catalog: N100HCT (Lot serial: S/N 23764 AND BELOW); Model Catalog: N1000DP (Lot serial: S/N 23764 AND BELOW); Model Catalog: K100S05 (Lot serial: S/N 23764 AND BELOW); Model Catalog: K100CIT (Lot serial: S/N 23764 AND BELOW); Model Catalog: SYS1000-L3DPA (Lot serial: S/N 23764 AND BELOW); Model Catalog: SYS1000-L3DPHA (Lot serial: S/N 23764 AND BELOW); Model Catalog: SYS1000-L3P (Lot serial: S/N 23764 AND BELOW); Model Catalog: SYS1000-L3PA (Lot serial: S/N 23764 AND BELOW); Model Catalog: SYS1000-L3PDP (Lot serial: S/N 23764 AND BELOW); Model Catalog: SYS1000-L3PH (Lot serial: S/N 23764 AND BELOW); Model Catalog: SYS1000-L3PHA (Lot serial: S/N 23764 AND BELOW); Model Catalog: SYS1000GIA (Lot serial: S/N 23764 AND BELOW); Model Catalog: SYS1000-L3PHDP (Lot serial: S/N 23764 AND BELOW)