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 Spectral CT 7500 [Product code: 728333] [HKMD No.: 220236].
According to the TGA, the manufacturer has identified an issue with the patient intercom on Philips Spectral CT 7500 systems that could affect the performance of the equipment. The patient cannot be clearly heard by the operator through the intercom on the CT Box in the operation room.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00546-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 Jun 2023