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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A problem could occur where user may calibrate collimator angle position readout in reverse switching the 90 degree and 270 degree positions. this could cause patient treatment with the wrong collimator angle for any collimator angle other than 0 degrees iec. a reversed calibration could cause any attempt to perform a remote auto motion of the collimator to result in a failure to reach the target position. in this case the collimator would rotate in the direction opposite the proper direction to reach the target angle and would reach the mechanical limit before reaching the target angle.
Model Catalog: 2100C (Lot serial: Contact manufacturer.); Model Catalog: 23EX (Lot serial: H290285); Model Catalog: TRILOGY (Lot serial: >10 Serial numbers.); Model Catalog: TRILOGY (Lot serial: Contact manufacturer.); Model Catalog: 2100C (Lot serial: >10 Serial numbers.); Model Catalog: 6EX (Lot serial: Contact manufacturer.); Model Catalog: CLINAC IX (Lot serial: >10 Serial numbers.); Model Catalog: CLINAC IX (Lot serial: Contact manufacturer.); Model Catalog: 600C (Lot serial: >10 Serial Numbers.); Model Catalog: 6EX (Lot serial: >10 Serial Numbers.); Model Catalog: NOVALIS TX (Lot serial: H294674); Model Catalog: 600C (Lot serial: Contact manufacturer.); Model Catalog: 21EX (Lot serial: Contact manufacturer.); Model Catalog: 21EX (Lot serial: >10 Serial numbers.)