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 Cochlear Limited Cochlear Nucleus 8 Sound Processors [HKMD No.: 240065].
According to the TGA, Cochlear has recently become aware of a problem that has resulted in certain Cochlear Nucleus 8 Sound Processors not being able to pair with compatible smartphones, CR310 Remote Controls or True Wireless devices.
This problem only affects devices manufactured and repaired between June 18, 2024, and October 1, 2024, and it has no impact on the safety of the device.
For further information, please visit: https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00901-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 Oct 2024