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 Medical Systems Nederland B.V. Zenition 50, 70 [Model Numbers: 718096, 718133] [HKMD number: 190388, 190389].
According to the TGA, touch functionality on the left monitor mounted on the Mobile View Station in Zenition 50 and Zenition 70 may not perform as intended.
For further information, please visit: https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00773-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 Sep 2024