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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The high voltage generator may stop working causing in a lack of x-ray generation and no image on the display. after rebooting the system works again. the malfunction is caused by software in the hv generator.
Model Catalog: ALLURA XPER FD10 (Lot serial: ); Model Catalog: 722016 (Lot serial: ); Model Catalog: ALLURA XPER FD20 (Lot serial: ); Model Catalog: ALLURA XPER FD10/10 (Lot serial: N/A); Model Catalog: 722043* (Lot serial: ); Model Catalog: ALLURA XPER FD20/10 (Lot serial: )