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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After reports of probe damage during four procedures the investigation concluded a 1.5 mri system interacted with the neuroblate probe such that radiofrequency (rf) energy was transferred to the proble resulting in unintended heating and damage at the tip of the probe.
Model Catalog: NB102-XX-R (Lot serial: all lots); Model Catalog: NB102-XX (Lot serial: all lots); Model Catalog: NB102 (Lot serial: all lots); Model Catalog: NB102-R (Lot serial: all lots)