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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Received twelve (12) complaints stating that the pedals of the footswitch/wireless type b are sticking and the zoom/focus is moving to the end position striking the patient's eye and potentially causing injury when a non-contact viewing system is attached.
Model Catalog: 10448406 (Lot serial: MORE THAN 10 SERIAL NUMBERS.); Model Catalog: 10445600 (Lot serial: MORE THAN 10 SERIAL NUMBERS.); Model Catalog: 10448164 (Lot serial: MORE THAN 10 SERIAL NUMBERS.); Model Catalog: 10445599 (Lot serial: MORE THAN 10 SERIAL NUMBERS.); Model Catalog: 10448407 (Lot serial: MORE THAN 10 SERIAL NUMBERS.)