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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Accuray has become aware of a potential safety issue related to the tomotherapy treatment system caused by a failure to monitor the jaw position after a jaw error occurs. this may result in an incorrect jaw position during treatment without generating a system interruption.
Model Catalog: 1018286 (Lot serial: Software ver 2.0.1/2.0.2/2.0.3); Model Catalog: H-0000-0003 (Lot serial: (Hi-Art 5.0.1/5.0.2/5.0.3)); Model Catalog: H-0000-0003 (Lot serial: Software ver 2.0.1/2.0.2/2.0.3); Model Catalog: 107825 (Lot serial: Software ver 2.0.1/2.0.2/2.0.3); Model Catalog: 1018284 (Lot serial: (Hi-Art 5.0.1/5.0.2/5.0.3)); Model Catalog: 1018284 (Lot serial: Software ver 2.0.1/2.0.2/2.0.3); Model Catalog: 1018286 (Lot serial: (Hi-Art 5.0.1/5.0.2/5.0.3)); Model Catalog: 107825 (Lot serial: (Hi-Art 5.0.1/5.0.2/5.0.3))