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.
The United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning Philips Medical Systems Nederland B.V. Allura Xper FD10, FD20, FD20 Biplane systems with an ADN7NT patient table [Model numbers: 722012, 722010, 722013; Software Version Number: 8.1.100] [HKMD No.: 100205, 100206, 110046, 110047, 110048].
According to the FDA, when Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=94647
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 27 May 2024