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