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 Food and Drug Administration (FDA) has posted a medical device safety alert concerning Siemens Healthcare GmbH syngo.via RT Image Suite upgraded to VB60 running on [syngo.via Model Number 10496180; SOMATOM go.Up Model Number 11061620; SOMATOM go.Sim Model Number 11061660 and SOMATOM go.Open Pro Model Number 11061670.] [HKMD No.: 180018].
According to FDA, the upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=89915
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 May 2022