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 Mobius Imaging, LLC Airo TruCT Mobile CT Scanner [Catalogue number: MOBICT-32; All Serial Numbers] [HKMD No.: 220345].
According to the TGA, the manufacturer is advising users on one report of an injury to an untrained user that occurred while the untrained user was moving an Airo TruCT unit in reverse. The Airo TruCT unit at issue did not experience a malfunction however the information on proper transport, which is already in the Airo TruCT User Manual, will now be affixed on labels to the Airo TruCT unit itself.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00336-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 Apr 2023