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 BV Philips Spectral CT7500 [Product code: 728333; Device identifier: 00884838101111; Serial numbers: 396001, 396003 and from serial number 10014 through serial number 10127] [HKMD No.: 220236].
According to TGA, for any scan type, if the Auto Voice and Breathing Lights buttons on the All Parameters tab are selected, it is possible that the automatic breathing instructions given by the system will be mismatched. The audio instructions to “Breath-In” are given by the system, but the “Breath-Out” Light Emitting Diode (LED) will light up. The “Breath-Out” audio instructions are also reversed with the “Breath-In” LED. The mismatch between the audio and visual breathing instructions may lead to patient confusion potentially resulting in a patient rescan being required.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00678-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 27 Jul 2023