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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Some observations have been made related to the holding brake inside the three instrument arms on the patient side cart. these brakes are automatically applied when there is no electrical power applied to the arms. these brakes are not required while the device is under electrical power. this action is being taken proactively. no complaints reportable incidents or reports of patient injury have been attributed to this issue.
Model Catalog: IS3000 (Lot serial: >10 serial numbers.); Model Catalog: IS3000 (Lot serial: Contact manufacturer.); Model Catalog: IS2000 (Lot serial: >10 serial numbers.); Model Catalog: IS2000 (Lot serial: contact manufacturer.)