Events

Safety Alert for ViewPoint 6

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by GE Healthcare.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-08-05
  • Event Date Posted
    2013-08-05
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130805a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: ge healthcare viewpoint 6 the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning viewpoint 6 versions 6.2, 6.2.1, 6.3 and 6.31 including ob pro-expert reporting (ultrasound image management software) manufactured by ge healthcare. ge healthcare has become aware of a potential safety issue due to the incorrect calculation of the pulsatility index value (piv) for venous flow measurements. the ductus venous piv measurement can be incorporated into the first trimester risk assessment for chromosomal abnormalities. in case of negative flow patterns, the viewpoint calculated doppler piv for veins could be incorrect, leading to a false high risk for trisomy 13, 18, and 21. ge healthcare is advising users to discontinue use of venous piv for making any clinical decisions, in particular, discontinue use of the ductus venous piv for first trimester risk assessment. in addition, ge healthcare will be providing a software upgrade as a permanent fix. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00812-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 august 2013.

Device

ViewPoint 6
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: GE Healthcare ViewPoint 6
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare