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
It has come to our attention that for digital linear accelerators of type artiste oncor and primus with serial numbers equal or higher than 3094: 1) incorrect values for the rotational collimator position may be displayed due to mechanical problems of the sensor slide 2) the overhead suspension might break due to an improper weld seam which might result in an injury of the patient.
Model Catalog: 7360717 (Lot serial: SN = OR > 3094); Model Catalog: 8139789 (Lot serial: SN = OR > 3094); Model Catalog: 04504200 (Lot serial: SN = OR > 3094)
제품 설명
ONCOR EXPRESSION DIGITAL LINEAR ACCELERATOR;ARTISTE MV-LINEAR ACCELERATOR-MAIN UNIT;MEVATRON LINEAR ACCELERATORS