BEUDAMED
    FDA Recall Open, Classified

    Sensica Urine Output System, Catalog Number SCCS1002

    Recall: Z-0554-2024 · Initiated November 15, 2023

    Recall

    Recall Number
    Z-0554-2024
    Event Number
    93375
    Firm
    C.R. Bard Inc
    FEI Number
    1018233
    Product Code
    EXS
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 15, 2023
    Posted
    December 14, 2023
    Address
    8195 Industrial Blvd Ne, Covington, GA, 30014-1497

    Description

    Sensica Urine Output System, Catalog Number SCCS1002

    Reason

    BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed during a patient monitoring session which resulted in 1) incorrect time displayed on the monitoring screen, 2) incorrect hour block timestamps on the monitoring screen, 3) incorrect hour timestamps on data screens, and 4) incorrect catheter use time.

    Action

    BD (CR Bard) issued an URGENT Medical Device Product Advisory to its consignees on 11/15/2023, via FedEx and email. The notice explained the problem with the device, potential hazard, and requested that the consignee perform Operating System and Sensica Software settings changes per the instructions provided on all devices within your facility s control using the attached directions.

    Distribution

    US Nationwide distribution.

    Quantity

    148 units