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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Carefusion has identified a potential risk with the alaris system model 8015 manufactured between september 11 2012 and march 29 2013. the units manufactured during this time frame may display a system error code 133.6080 due to a failure with the super capacitor (c245) at power up on the alaris system logic boards (part numbers tc 10007253 and tc 100006939).
Model Catalog: SERIAL #S 138XXXX >100 (Lot serial: 8015); Model Catalog: SERIAL #S 12706344 (Lot serial: 8015); Model Catalog: SERIAL #S 137XXXXX > 100 (Lot serial: 8015); Model Catalog: SERIAL #S 13691087 (Lot serial: 8015); Model Catalog: SERIAL #S 12992376 (Lot serial: 8015)