BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0268-2018 · Initiated September 20, 2017

    Recall

    Recall Number
    Z-0268-2018
    Event Number
    78733
    Firm
    Philips Electronics North America Corporation
    FEI Number
    1218950
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    September 20, 2017
    Posted
    December 20, 2017
    Terminated
    April 17, 2020
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    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.

    Action

    Philips sent each known affected customer a Field Safety Notice, dated September, 2017. The Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. Philips will provide a corrected label free of charge

    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