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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Philips volcano is initiating a voluntary correction to address a configuration issue that affects some s5i and core mobile systems with software version v3.5 ("impacted systems"). on certain impacted systems an unexpected microsoft windows security dialog may appear during use and the user's response to the dialog may adversely affect the subsequent operation of the device. the microsoft windows security settings on a small number of impacted systems were incorrectly configured during the manufacturing process. this misconfiguration can lead to a windows security alert dialog being displayed when the system is switched from ivus to the ffr/ifr mode. if the user responds to the dialog by selecting "allow access" the device's network firewall settings will be modified opening its network ports to potential unexpected communication from the hospital network to which the device is connected. unexpected communication from the hospital network could include normal network security operations e.G. port scanning. if these communications occur during an active ffr/ifr procedure data recording could be affected leading to: -incorrect ffr/ifr measurements -case delay during troubleshooting and/or port scanning -abandonment of use of the system based on our investigation there is only a remote probability that any of these impacts may occur. (see s64 for french translation).