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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This recall has been initiated to address a deadlocking issue with eye station import utility (esiu). esiu is designed to import images and reports to be reviwed on merge eye care pacs or merge eye station. there have been reports of esiu locking up which prevents data import.
Model Catalog: MERGE EYE CARE PACS (Lot serial: 1.1.3); Model Catalog: MERGE EYE CARE PACS (Lot serial: 1.1.2); Model Catalog: MERGE EYE CARE PACS (Lot serial: 1.0); Model Catalog: MERGE EYE CARE PACS (Lot serial: 1.1); Model Catalog: MERGE EYE CARE PACS (Lot serial: 1.1.1)