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, Philips Medical Systems Nederland B.V., has issued a medical device safety alert concerning its Magnetic Resonance (MR) systems [HKMD Number: 110311, 110501, 120210, 190186, 190390, 200408 and 200409].
The manufacturer has identified an issue with certain MR room cage installations where the patient support (table) floor plate may have been incorrectly installed during construction of the MR suite. This may cause the table to become dislodged from the floor and potentially cause harm to the patient and/or operator. If the patient support were to become dislodged from the floor, the risk to patients or operators may include physical harm from falling from the table, pinching of extremities or other body parts between the patient support and system or floor, and/or delayed diagnosis.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 25 Mar 2024