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.
데이터 추가 비고
원인
There is a possibility that screws holding an internal portion of the gantry (reaction ring) to the scanner's main bearing may come loose. if this occurs the part(s) will not be expelled however a noise may be heard coming from the gantry. there is no potential for harm to the patient or operator due to this issue. raison du rappel il est possible que des vis retenant une partie interne du statif (anneau de reaction) au mecanisme de soutien de l'appareil d'irm se devissent. si cela se produit la ou les pieces ne seront pas expulsees.Cependant un bruit peut etre entendu en provenance du statif. il n'y a aucun risque de lesion au patient ou a l'operateur decoulant de ce probleme.