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 Olympus Medical Systems Corp. GIF-1TH190 Gastrointestinal Videoscope [Serial number range: Before 2446103 or After 2500453] [HKMD No.: 160279].
According to the TGA, the current Instructions For Use (IFU) addendum is deemed ineffective in ensuring the drying procedure instructions provide sufficient endoscope channel drying directions.
For further information, please visit: https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00897-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 14 Oct 2024