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 Big Bore RT, Brilliance CT Big Bore, Brilliance CT Big Bore Oncology [Product Code (Ref): 728242, 728243, 728244; Software: V4.8.0.10421; Device Identifier: (01)00884838095168, (01)00884838059450] [HKMD No.: 200303].
According to the MHRA, after performing an off-center reconstruction and sending the image data to other Therapy Planning Solution (TPS) workstations or exporting to a post processing software, a two-dimensional image shift (X and Y coordinates) may occur. In oncology scenarios this could cause the contours to be misplaced or the ISO center of the tumor to be incorrect. In radiology scenarios this could cause the Relate function to show different positions on the IntelliSpace Portal or other post-processing workstations, when comparing images.
For further information, please visit https://mhra-gov.filecamp.com/s/d/BcaizYMdnqDROslq
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 1 Nov 2023