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 United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Philips Medical Systems Nederland B.V. Spectral CT 7500 (728333), Spectral CT 7500 China (728340), and Spectral CT on Rails (728334) [HKMD No.:220236].
According to the MHRA, the manufacturer has identified that there is a software issue that can incorrectly label all captured images as the “Last Shot”. This situation can occur under the following circumstances:
According to the manufacturer, if this issue occurs, it could potentially cause misdiagnosis and subsequent incorrect treatment. This can be due to needle position uncertainty based on the use of an image taken prior to the last shot.
For further information, please visit https://mhra-gov.filecamp.com/s/d/x9O4doOcoXEVCtiQ
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 Dec 2023