Events

Recall of RTVUE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CLARION MEDICAL TECHNOLOGIES INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    135258
  • Event Risk Class
    III
  • Event Initiated Date
    2016-04-18
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    A minor software upgrade for optovue device families were released on february 22 2016. the device families are the ivue (rtvue - ivue100) ifusion and ivue500 (iscan in the us). the software configuration is 2016.1.0.127 (outside the us only). the device user will perform a scan of a patient's retina. they may then review the data within a series of available reports. two reports are affected by the software anomaly: (1) retina map ou report and (2) iwellness ou report. for example in the new retina map ou report the user may scroll on the map" or the "b-scan" image of either eye. this activates the software anomaly and makes both b-scans identical (i.E. - both show the same eye). whether both eyes become left or right depends on how you enter the report. for example entering the ou report from the od (right eye) report will cause both b-scans to be right eye when scrolling is attempted.

Device

RTVUE

Manufacturer

CLARION MEDICAL TECHNOLOGIES INC.