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
The patient support table top may fail to move in the horizontal direction when it is commanded to do so during ct scans due to a potential mechanical linkage failure. the system cannot automatically detect this failure to abort the scan or to alert the user. of the 5000 ct systems potentially affected there have been 2 occurrences of this failure mode in the past 10 years.
Model Catalog: 4535 670 88051 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 4550 110 09021 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 4550 110 04011 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 728311 (Lot serial: 200071); Model Catalog: 453567005721 (Lot serial: 6149); Model Catalog: 453567005721 (Lot serial: 6150); Model Catalog: 728306 (Lot serial: 100195); Model Catalog: 728306 (Lot serial: 100223); Model Catalog: 4535 670 78851 (Lot serial: 6352); Model Catalog: 728306 (Lot serial: 100206); Model Catalog: 728306 (Lot serial: 100249); Model Catalog: 728306 (Lot serial: 100101); Model Catalog: 728306 (Lot serial: 100290); Model Catalog: 728306 (Lot serial: 100046); Model Catalog: 728306 (Lot serial: 100440); Model Catalog: 728326 (Lot serial: 30003); Model Catalog: 728326 (Lot serial: 30004); Model Catalog: 728323 (Lot serial: 30004); Model Catalog: 728323 (Lot serial: 320148); Model Catalog: 728326 (Lot serial: 320148); Model Catalog: 728323 (Lot serial: 320123); Model C
제품 설명
BRILLIANCE CT BIG BORE SYSTEM - MAIN UNIT;BRILLIANCE 40/64 SLICE CT SYSTEM;BRILLIANCE ICT SP SYSTEM - MAIN;BRILLIANCE CT SYSTEM (16P);BRILLIANCE ICT SYSTEM - SYSTEM;BRILLIANCE 6/10/16 SLICE CT SYSTEM;INGENUITY CT SYSTEM