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 Azurion Systems with software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 [Model Number: 722063, 722221, 722064, 722222, 722227, 722228, 722067, 722225, 722068, 722226, 722078, 722223, 722079, 722224] [HKMD No.: 200480 and 230373].
According to the manufacturer, during the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an X-ray image). The pedal tap may cause a dark image with the next fluoroscopy run.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 Dec 2023