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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Philips has become aware that memory problems on the embedded technology extended (etx)-module in the system interface board (sib) box cause intermittent failures. the sibbox plays a role in starting and stopping and controlling the image functionality. although highly intermittently the failure can occur both during startup as during system use. the failure does not affect an active x-ray run and the run can be finished. however no new run can be started until the system is rebooted. as such the failure has no impact on the critical moment in a critical procedure.
Model Catalog: ALLURA XPER FD20/10 (Lot serial: ALL); Model Catalog: ALLURA XPER FD10/10 (Lot serial: ALL); Model Catalog: 000454 (Lot serial: ALL); Model Catalog: ALLURA XPER FD20 (Lot serial: ALL); Model Catalog: ALLURA XPER FD20/20 (Lot serial: ALL); Model Catalog: ALLURA XPER FD10 (Lot serial: ALL)