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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Notifying users in canada of an updated test procedure for the power-fail alarm of the iw900 series infant radiant warmer. the service manual already includes a requirement for an annual check of the power-fail alarm. the test procedure has been revised to check that the power-fail alarm operates for at least 12 minutes. the revised test procedure accounts for any unexpected degradation over time of the supercapacitor that operates the power-fail alarm.
Model Catalog: IW910 (Lot serial: All Infant Warmers in Canada.); Model Catalog: IW920 (Lot serial: All Infant Warmers in Canada.); Model Catalog: IW930 (Lot serial: All Infant Warmers in Canada.); Model Catalog: IW932 (Lot serial: All Infant Warmers in Canada.); Model Catalog: IW934 (Lot serial: All Infant Warmers in Canada.); Model Catalog: IW950 (Lot serial: All Infant Warmers in Canada.); Model Catalog: IW980 (Lot serial: All Infant Warmers in Canada.); Model Catalog: ABOVE SERIES WITH SUFFIX JEU (Lot serial: All Infant Warmers in Canada.)