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 Healthcare Philips Incisive CT PIM [PIM cable part number: 459801179871; Product numbers: 728143 & 728144] [HKMD No.: 180534].
According to the TGA, the manufacturer has identified a reliability problem with the PIM (Patient Interface Monitor) cable provided with the Incisive CT system that could affect the performance of the equipment. If the PIM cable’s connector is plugged/unplugged frequently as part of daily operation, the connector and wire may disconnect from the welding point. This disconnection may result in intermittent loss of the ECG signal. If the ECG signal is unavailable during a cardiac scan and the obtained image(s) are not sufficient for clinical diagnosis, the operator may decide to rescan the patient.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01354-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 14 Nov 2022