Events

Safety Alert for Avance CS2

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
    2013-04-05
  • Event Date Posted
    2013-04-05
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130405.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 avance cs2 the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning avance cs2, manufactured by ge healthcare. the avance cs2 may experience an intermittent display unit failure while in use, which could result in unexpected system performance and may include the loss of mechanical ventilation and balance gas delivery (medical air or n2o). according to the manufacturer, users may continue to use avance cs2, however in the event the display goes blank, users should stop use of the device and contact local ge healthcare representative. if the display goes blank, an audible alarm will notify the user of the loss of mechanical ventilation. below are the avance cs2 safety precautions in place if this should occur: alt o2 automatically activates, continuing to flow o2 and agent concentration (prevailing setting) at the previous setting to the patient breathing circuit. manual ventilation is available. furthermore, ge healthcare will correct all affected systems. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con252005 if you are in possession of the product, please contact your supplier for necessary actions. posted on 5 april 2013.

Device

Avance CS2
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: GE Healthcare Avance CS2
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare