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 Philips Azurion System R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2 [Model Number: 722063, 722221, 722064, 722222, 722227, 722228, 722067, 722225, 722068, 722226, 722078, 722223, 722079, 722224, 722280] [HKMD No.: 200480 and 230373].
The manufacturer has identified a potential issue which can cause the system to continuously restart (restart loop). This is likely to occur when the patient database gets too big over time (>500 studies). If this issue occurs, a potential for data loss may be expected.
If this issue occurs, the Philips Azurion system might not recover from this fault situation causing the system to not be available. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 Dec 2023