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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One complaint was received where the remote alarm of an affected instrument did not alert the customer properly of an error that occurred during processing. a review meeting was held by the manufacturer to determine that the drawing of the remote alarm cable does have an error which led to a malfunction of the remote alarm. cables with this error were used since april 24 2013 in production. a shiphold of the asp200s/asp300s was initiated on july 13 2015. within this time period 901 instruments were distributed globally with the affected cables. the affected devices have an incorrect internal wiring to the remote alarm plug which can cause the remote alarm to not function correctly in the case of an instrument failure.