The Australia Therapeutic Goods Administration (TGA) posted a medical device safety alert concerning Symbia T Series and Symbia Intevo Camera System manufactured by Siemens Ltd.
The manufacturer recently detected a rubber isolator with unfavourable aging properties. The function of this rubber isolator, which is situated within the rotate motor mounting assembly, may degrade over time and may impact motor support. In rare cases, when unfavourable aging has occurred, the rubber isolator may break and cause loss of support for the rotate motor. This event could lead to a rupture of the drive belt which in turn could damage the gantry covers and make contact with the patient. The possibility of a serious injury does exist if the belt makes contact with the patient.
The manufacturer advises customers that they can continue to use the systems while waiting for the corrective action to be undertaken which includes new mounting plate with improved rubber components and a backup device to ensure trouble free operation in the future.
Users are advised to immediately discontinue use of the affected product and contact their service engineer if they are experiencing abnormal noise or vibration. Users are also asked to ensure that the safety advisory is placed in the System Owner's Manual.
For details, please refer to TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00881-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 August 2014