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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Manufacturer has become aware of unintended movement occurring during surgical cases due to the use of damaged remotes. no patients or users have been injured. there is a possibility that damage can occur to a remote control which breaks the button and can cause permanent or sporadic electrical conduction and trigger unintended movement. this is a rare event and can be avoided by proper handling and maintenance of the remote control. the product is safe as long as it is not damaged.
Model Catalog: 1276277 (Lot serial: All Lots); Model Catalog: 4500112 (Lot serial: All Lots); Model Catalog: 4500113 (Lot serial: All Lots); Model Catalog: 1574977 (Lot serial: All Lots); Model Catalog: 4500170 (Lot serial: All Lots); Model Catalog: 1389826 (Lot serial: All Lots); Model Catalog: 1622774 (Lot serial: All Lots); Model Catalog: 1223188 (Lot serial: All Lots); Model Catalog: 1389824 (Lot serial: All Lots)