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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The thickness and location of the shielding material must be installed according to the shielding requirements provided by philips. in cases where the requirements are not followed the distance between the passive shielding rear wall and the magnet could be insufficient. an insufficient distance leads to stronger attraction forces between the magnet and the passive shielding. these stronger forces may lead to shearing of the magnet vibration pads. in a worst case scenario it may result in displacement of the magnet. displacement of a magnet can result in image quality issues and mechanical fitting problems with the table. these functional issues affect the clinical usage of the mr system.