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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Philips has become aware of the following issues: 1. the system may sporadically apply the default x-ray exposure parameters for an adult (patient type: "normal") even though the patient type "newborn" was selected and is displayed in the generator control area of the eleva user interface. 2. under certain conditions the detector might not be ready for examination. released x-ray might lead to an image with artifacts and a retake is required. while the attachment process is running the detector might be too short in front of the ir (infrared) sensor and the problem of the washed out images can appear if an exposure is taken right after that.