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 manufacturer, RaySearch Laboratories AB (publ), has issued a medical device safety alert concerning its RayStation/RayPlan 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A [HKMD numbers: 180268].
The manufacturer has received two reports of patient mistreatment after users selected “Silicon” when creating a material override for a silicone gel polymer implant. The pure Silicon in the material list has a density of 2.33 g/cm3 while the correct density of silicone gel polymers is close to that of water. The incorrect material selected led to a radiation overdose to the patients.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 Feb 2024