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 Volcano Corporation (Philips Electronics Australia Ltd) Philips OmniWire Pressure Guide Wire [All OmniWire Pressure Guide Wires manufactured since February 2022 (2022-02-01)] [HKMD No.: 220274].
According to the TGA, there is a potential problem with OmniWire Pressure Guide Wire where an internal wire component could become damaged due to the wire not meeting an internal specification. The wire component serves to transfer the signal from the sensor to the core. This condition could cause continuity problems that result in compromised electrical integrity including electrical short, no signal, loss of signal, or intermittent signal.
For further information, please visit: https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00848-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 27 Sep 2024