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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A very small number of incidents have been reported for another model (1500t12) of ibi therapyt generator where the generator initiated the unintended delivery of rf energy when the user was making settings adjustments. the generator is designed to only initiate rf energy when the start/stop key is pressed. however due to a potential for internal circuitry damage caused by electrostatic discharge the generator controls may be adversely affected. although no such incidents have been reported with the 1500t14 generator it contains the same internal circuitry as the 1500t12 generator that is vulnerable to potential damage caused by electrostatic discharge. as a result it is being included in this action.
“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.