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
Philips healthcare received a report from the field that during a manual collimator exchange procedure the operator was attempting to slide the collimator cassette containing the detector 2 vertex high resolution (vxhr) collimator from the collimator storage cabinet onto the collimator exchange carriage. as the vxhr collimator and collimator cassette was being slid onto the carriage the cassette did not align with the carriage top guide rollers and mechanical lock. the collimator and collimator cassette fell off of the carriage and onto the floor.