BEUDAMED
    FDA Enforcement Class III Terminated

    Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.

    Recall: Z-0268-2018 · Reported December 27, 2017

    Enforcement

    Recall Number
    Z-0268-2018
    Event ID
    78733
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Electronics North America Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 27, 2017
    Initiation Date
    September 20, 2017
    Classification Date
    December 20, 2017
    Termination Date
    April 17, 2020
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032, United States

    Description

    Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.

    Reason

    Some SureSigns VSi, VS2+ products have the Date of Manufacture on its serial number label as %DoM , instead of the specific date in the format of YYYY-MM.

    Code Info

    SureSigns VSi : 863275, 863276, 863277 SureSigns VS2+ : 863278, 863279

    Distribution

    Worldwide distribution. Australia, Austria, Bahrain, Belgium, Brazil, Denmark, France, French Polynesia, Germany, Hong Kong, India, Ireland, Israel, Italy, Kenya, Lebanon, Lesotho, Malaysia, Maldives, Morocco, Netherlands, Oman, Pakistan, Palestine, Poland, Saudi Arabia, South Africa, Spain, Sweden, Thailand, Turkey, United Kingdom, UAE, Vietnam, and Zimbabwe.

    Quantity

    1079