BEUDAMED
    FDA Enforcement Class II Terminated

    VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.

    Recall: Z-1408-2015 · Reported April 15, 2015

    Enforcement

    Recall Number
    Z-1408-2015
    Event ID
    70927
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    VasoNova, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 15, 2015
    Initiation Date
    March 30, 2015
    Classification Date
    April 9, 2015
    Termination Date
    April 11, 2016
    Address
    155 Jefferson Dr, N/A, Menlo Park, CA, 94025-1114, United States

    Description

    VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.

    Reason

    A limited number of VPS G4 Consoles are being recalled due to noncompliance with International Electrotechnical Commission Standard 60101-1-1.

    Code Info

    Product code VPS-G4C; Serial numbers: GB40129, GB40130, GB40131, GB40133, GB40136, GB40146, GB40148, GB40151, GB40152, GB40154, GB40155, GB401456, GB40157, GB40158, GB40168, GB40175, GB40186

    Distribution

    US Nationwide Distribution in the states of AZ, DC, PA, IN, PA. GA, NY, KS, CA, VA, NC.

    Quantity

    17