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Safety Alerts and Communications

Safety Alerts

Safety Alerts

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.

Medical Device Safety Alert: Philips Medical Systems Nederland B.V. Spectral CT systems or the Spectral CT on Rails systems

15 Nov 2024

The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Philips Medical Systems Nederland B.V. Spectral CT systems or the Spectral CT on Rails systems [Product code: 728334, 728333 and 728340] [HKMD No.: 220236].

According to the TGA, the manufacturer has identified two problems that could affected the performance of the Philips Spectral CT systems or the Spectral CT on Rails systems.

Problem 1: An interruption during the "get ready for scan" stage of a scan or an interruption during air calibration may occur. If this occurs it may require a system reboot or if this occurs during a scan it could result in a partial set of images and patient may require a rescan.

Problem 2: A synchronisation problem in the Firmware can result in an image quality problem where a dead layer will appear as a ring/band artifact. If this occurs during a scan it could result in a partial set of images and patient may require a rescan.

For further information, please visit: https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-01022-1

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 15 Nov 2024

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