BEUDAMED
    FDA Recall Terminated

    91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP. Option B: ECG/Respiration, Invasive Pressure x2, SpO2, Temperature x2 & adult/neonate NIBP. Option C: ECG/Respiration, Invasive Pressure x4, SpO2, Cardiac Output, Temperature x2 & adult/neonate NIBP. Option I: SpO2, Temperature x2, & adult/neonate NIBP.

    Recall: Z-2343-2016 · Initiated July 1, 2016

    Recall

    Recall Number
    Z-2343-2016
    Event Number
    74549
    Firm
    Spacelabs Healthcare Inc
    FEI Number
    3010157426
    Product Code
    DSI
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    July 1, 2016
    Posted
    August 4, 2016
    Terminated
    May 22, 2017
    Address
    35301 SE Center St, Snoqualmie, WA, 98065-9216

    Description

    91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP. Option B: ECG/Respiration, Invasive Pressure x2, SpO2, Temperature x2 & adult/neonate NIBP. Option C: ECG/Respiration, Invasive Pressure x4, SpO2, Cardiac Output, Temperature x2 & adult/neonate NIBP. Option I: SpO2, Temperature x2, & adult/neonate NIBP.

    Reason

    The firm has received multiple reports of the Non-Invasive Blood Pressure (NIBP) parameter becoming non-functional with an associated message (No Reading). In addition, there is one of the following three error messages: Inflate Error, HW Error, or No Data.

    Action

    Spacelabs expanded the recall and sent an Urgent - Medical Device Correction letter dated August 30, 2016, to additional affected customers via priority mail (return receipt requested). On September 6, 2016, a customer letter (translated as necessary) was sent via email to all international subsidiaries and distributors of record. ********************************************************************************************** Spacelabs Healthcare Inc, sent an Urgent - Medical Device Correction letter dated July 1, 2016, to all affected customers (return receipt requested). On July 8, 2016, a customer letter (translated as necessary) was sent via email to all international subsidiaries and distributors of record. Spacelabs Healthcare will contact customers to schedule a convenient time for a Spacelabs service technician to update their affected Command Module(s) at no cost. For additional information or technical assistance, please contact: Technical Support 1-800-522-7025 and select (2) for Technical Support

    Distribution

    Worldwide Distribution - USA Distribution and to the countries of : AFGHANISTAN, ARGENTINA, AUSTRALIA, BAHRAIN, BOLIVIA, BRAZIL, BRUNEI DARUSSALAM; CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DOMINICAN REPUBLIC; ECUADOR, EGYPT, ESTONIA, FRANCE, GERMANY, GUATEMALA, HONG KONG, INDIA, IRAN (ISLAMIC REPUBLIC OF), ISRAEL, ITALY, JORDAN, KUWAIT, MEXICO, MOROCCO, NETHERLANDS, NICARAGUA, PAKISTAN, PALESTINE, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, Slovakia, SPAIN, SRI LANKA, SWITZERLAND, TAIWAN, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VIET NAM.

    Quantity

    3801 modules and 116 PCBAs & valves distributed in the US; 1297 modules and 366 PCBAs & valves distributed outside the US