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
Carestream has identified a software issue that if the image suite software receives computed tomography (ct) and magnetic resonance (mr) images with the image orientation (patient) tag specified and the overlay is configured to display this tag the l (left) and r (right) and a (anterior) and p (posterior) overlay text could be displayed reversed.
Model Catalog: 1056191 (Lot serial: 85013463); Model Catalog: 1036490 (Lot serial: 54842775); Model Catalog: 1036490 (Lot serial: 52412542); Model Catalog: 1036508 (Lot serial: 54842775); Model Catalog: 1036508 (Lot serial: 52412542)
제품 설명
IMAGE SUITE 4.0 WITH MINI-PACS AND DICOM STORE;IMAGE SUITE 3.0 WITH MINI-PACS OPTIONS AND HOT FIX 3004 SOFTWARE PATCH;IMAGE SUITE 3.0 WITH MINI-PACS OPTIONS AND HOT FIX 3004 SOFTWARE