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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Siemens is notifying users of a potential issue with the acuson sc2000 ultrasound system with software versions vb10a vb10b vb10d and vb10e. the 3d esie pisa volume analysis application quantifies valvular regurgitation. while imaging with the z6ms volume transesophageal echocardiography transducer this application may underestimate the eroa (effective regurgitant orifice area) in comparison to the same patient results obtained with the 4z1c volume transthoracic echocardiography transducer.