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
Adequate precautions and exercising due care is needed in all aspects of gantry motions particular remote motions. failure to follow the instructions in varian's user documentation warnings and other product labeling may increase the risk of a collision between the accelerator gantry and the patient couch or nearby equipment or personnel. such collisions can occur on any clinac trilogy trilogy tx and novalis tx accelerator.
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: 23EX (Lot serial: H271208); Model Catalog: 2100C (Lot serial: Contact manufacturer.); Model Catalog: 21EX (Lot serial: Contact manufacturer.); Model Catalog: 21EX (Lot serial: >10 Serial numbers.); Model Catalog: NOVALIS TX (Lot serial: H271992); Model Catalog: 6EX (Lot serial: Contact manufacturer.); Model Catalog: 600C (Lot serial: Contact manufacturer.); Model Catalog: 6EX (Lot serial: >10 Serial numbers.); Model Catalog: 600C (Lot serial: >10 Serial numbers.); Model Catalog: CLINAC IX (Lot serial: Contact manufacturer.); Model Catalog: CLINAC IX (Lot serial: >10 serial numbers.)