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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원인
Fisher & paykel healthcare is issuing this voluntary recall notice because it has had two confirmed reports of breakage of the nut that secures the heater head in place. breakage of the nut can cause the heater head to become partially detached and swing towards the bassinet. the heater head did not contact the patient in either case. however there is the potential that a heater head could contact a patient situated on the bassinet and cause a serious injury.
Model Catalog: IW952 (Lot serial: 071208002349 TO 090717000930); Model Catalog: IW980 (Lot serial: 071208002349 TO 090717000930); Model Catalog: IW920 (Lot serial: 071208002349 TO 090717000930); Model Catalog: IW910 (Lot serial: 071208002349 TO 090717000930); Model Catalog: 648040142 (Lot serial: 071116 TO 090810); Model Catalog: 043042359 (Lot serial: 071116 TO 090810); Model Catalog: 043041130 (Lot serial: 071116 TO 090810); Model Catalog: IW954 (Lot serial: 071116 TO 090810); Model Catalog: IW953 (Lot serial: 071116 TO 090810); Model Catalog: IW951 (Lot serial: 071116 TO 090810); Model Catalog: IW990 (Lot serial: 071116 TO 090810); Model Catalog: IW934 (Lot serial: 071116 TO 090810); Model Catalog: IW933 (Lot serial: 071116 TO 090810); Model Catalog: IW932 (Lot serial: 071116 TO 090810); Model Catalog: IW931 (Lot serial: 071116 TO 090810); Model Catalog: IW952 (Lot serial: 071116 TO 090810); Model Catalog: IW980 (Lot serial: 071116 TO 090810); Model Catalog: IW920 (Lot serial: 071116 TO 090810); Model Cat