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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Due to intermittent shortcuts inside the velara generator a system lock-up might occur that can only be resolved by a warm or cold system restart. in exceptional cases the generator is damaged and the system cannot be restarted. as this is an intermittent failure no work around is available and no actions can be done by the user to prevent the failure from happening.
Model Catalog: ALLURA XPER FD10 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: ALLURA XPER FD20 (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: 722016 (Lot serial: 34660); Model Catalog: ALLURA XPER FD10/10 (Lot serial: SN09004890); Model Catalog: ALLURA XPER FD10/10 (Lot serial: SN085194); Model Catalog: ALLURA XPER FD10/10 (Lot serial: SN085257); Model Catalog: 722043* (Lot serial: 44701); Model Catalog: ALLURA XPER FD20/10 (Lot serial: SN064966); Model Catalog: ALLURA XPER FD20/10 (Lot serial: SN074546)