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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Several software issues which will be corrected with the release of a new software version. 1-following a cardiac scan and when using smartstep to setup the camera for a relative 180 procedure it is possible for detector 1 to collide with the head holder when moving from the position at which the flat panel is deployed. this affects only the brightview xtc systems. 2-during a patient spect lung acquisition the clinical scan acquisition protocol commanded the gantry rotation to move from the 45 degree to the 90 degee position. however in the middle of a clinical scan acquisition the detector heads moved away from the patient (centre of rotation) in an uncommanded motion and subsequently the gantry unexpectedly rotated to the 240 degree position. the movement from 90 degrees to the 240 degrees may take approximately 7 seconds. 3-at the completion of a thyroid procedure the operator executed the pinhole pre-programmed motion (ppm) and noticed a change in the sequence of motions between the imaging pallet and the detector radius. the system moved the patient pallet from the gantry before the detector installed with the pinhole collimator was moved out of the path of the patient. this sequence of motions differed from the previous software release. this affects systems with software version 1.2.3/2.5.3.