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 model 3120 programmers distributed in canada are mislabeled. the the affected programmers do not included software to program confient implantable cardioverter defibrillator and livian cardiac resynchronization therapy-defibrillator. the software models are model 2888 and model 2945 respectively for confient and livian. model 3120 programmers with missing model 2888 and 2945 software will not be able to interrogate or program confient/livian defibrillators until the software has been loaded.
“We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”