Events

Safety Alert for acuson sc2000 ultrasound systems

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

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
    2014-01-07
  • Event Date Posted
    2014-01-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140107a.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: siemens acuson sc2000 ultrasound systems the australia therapeutic goods administration (tga) posted a medical device safety alert concerning acuson sc2000 ultrasound systems manufactured by siemens ltd. according to the manufacturer, the user interface module on the ultrasound system consists of the console (monitor, control panel and keyboard) and the swivel mechanism.The swivel mechanism is used for adjusting the height and rotation of the console and is attached to the column on the ultrasound system. if the connection of the user interface module to the column on the ultrasound system is loose, the entire module may fall off the ultrasound system resulting in injuries. the manufacturer advises end users to inspect their units for any looseness in the attachment of the interface module to the column on the ultrasound system. if looseness is observed, the user should discontinue use of the device immediately and contact the manufacturer. a service engineer will perform the necessary repairs. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00005-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 7 january2014.

Device

acuson sc2000 ultrasound systems
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Siemens ACUSON SC2000 Ultrasound Systems
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd