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 SenTec AG V-Sign Sensor 2 [REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS); Serial numbers 338947, 338952, 338953, 338963, 338967, 338989, 338991, 338993, 338994, 338996, 338997; UDI-DI 07640121880513] [HKMD No.: 200487].
According to the FDA, the sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "released" mode.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=92355
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 Jun 2023