BEUDAMED
    FDA Recall Terminated

    Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature Product Usage: The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

    Recall: Z-0824-2013 · Initiated January 14, 2013

    Recall

    Recall Number
    Z-0824-2013
    Event Number
    64070
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    DXN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 14, 2013
    Posted
    February 14, 2013
    Terminated
    August 27, 2020
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature Product Usage: The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

    Reason

    VS2+ screen may lock up and stop monitoring during patient use

    Action

    Philips issued an Urgent Medical Device Correction letter on January 14, 2013. The field action will take place in two phases: Phase 1 Philips sent customer an Urgent Medical Device Correction Notification/Field Safety Notice. This notification explains the issues and gives the customers instructions on actions to take while they await the hardware correction. Phase 2 Once the hardware correction Philips will contact customers and perform the correction free of charge. Until the correction is available. Affected products may continue to be used while waiting for the correction from Philips if the unit is not used in NBP interval mode. A Philips Healthcare representative will contact you to arrange for the correction of all affected devices. If you need any further information or support concerning this issue, please contact the Philips Customer Care Center at 1-800-722-9377. On 3/14/13, firm stated Initially the fix would be a hardware upgrade but have since changed that to a software update. Customers within the US will be sent a new Field Safety Notice as well as a USB software update package and will be required to notify us upon the upgrade of their affected units. They will be performing the updates themselves

    Distribution

    Worldwide Distribution - US Nationwide and the countries of: AUSTRALIA, AUSTRIA, BELGIUM,CANADA, CHILE, DENMARK, FRANCE GERMANY, ICELAND, INDIA, IRELAND,ISRAEL,ITALY, JORDAN, KENYA KUWAIT, LEBANON, MALAYSIA, NAMIBIA, NETHERLANDS, NEW ZEALAND NORWAY,PALESTINE, POLAND,PORTUGAL, SAUDI ARABIA, SINGAPORE SLOVENIA, SOUTH AFRICA, SOUTH KOREA,SPAIN,SWEDEN, SWITZERLAND THAILAND, TRINIDAD AND TOBAGO, UNITED ARAB EMIRATES UNITED KINGDOM

    Quantity

    3248 units