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 Philips Interventional Hemodynamic Application R1.2.X, R1.3.0 and R1.3.1 [HKMD No.: 200291].
According to the manufacturer, it has become aware of a potential issue with Philips Interventional Hemodynamic Application R1.2.X, R1.3.0 and R1.3.1, where synchronization of pressure wave data received from two devices – the IntelliVue X3 and Functional Measurement Patient Interface Module (FM-PIM) – may not be correct. There might be a delay of the FM-PIM data with respect to the IntelliVue X3 data which is not constant in time. When this occurs, the calculation of measurements will be affected, specifically the iFR (instantaneous wave-free ratio) and FFR (fractional flow reserve) values.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 9 May 2024