The Therapeutic Goods Administration (TGA), Australia has issued a medical device safety alert concerning E.cam and Symbia E systems [Siemens reference number: MI017/13/S; Serial number: All], manufactured by Siemens Ltd.
The manufacturer has received reports of loose bolts on system detectors for Symbia E and e.cam, which secure the detectors to the yoke. The manufacturer is advising users that all affected units will be inspected for loose screws and corrected if required. Affected units can continue to be used.
For details, please visit the following MHRA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01118-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 November 2013