Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Philips SmartPath to dStream and Ingenia systems [Product code : 781341, 781396, 781261, 781262, 781260, 781271, 781342, 781377, 781347 and 781270] [HKMD No.: 190186].
According to the TGA, the manufacturer has identified an issue with the tabletop docking interface used for SmartPath to dStream and Ingenia systems. The purpose of the tabletop is to carry the patient during patient preparation and scanning. This issue is related to a potential instability of the tabletop when locked on the FlexTrak trolley.
The SmartPath to dStream and Ingenia system tabletops have a docking interface, which is located underneath the tabletop and attached with screws.
The screws fixating the tabletop docking interface may come loose, potentially leading to disengagement or some instability of the tabletop when clamped on the FlexTrak Trolley. The manufacturer has confirmed that this potential issue impacts systems manufactured prior to May 2016.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01102-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 25 Aug 2022