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 B.V. Philips Spectral CT7500 [Product code: 728333; Device Identifier numbers: 00884838101111, 00884838111103] [HKMD No.: 220236].
According to the TGA, the HIB-CIB cable on the NOAH couch may wear unexpectedly over time. During vertical couch motion, if the HIB-CIB cable has been damaged, the system may engage the Emergency Stop intermittently. If the Emergency Stop is engaged both motion and X-rays will stop. If this occurs during a scan it could result in a partial set of images, and a patient rescan may be required.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00304-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 Apr 2024