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 Medtronic Inc. SynchroMed [Model: A810] [HKMD No.: 090082].
According to the FDA, the previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=93401
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 Dec 2023