BEUDAMED
    FDA Recall Open, Classified

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    Recall: Z-1793-2026 · Initiated February 27, 2026

    Recall

    Recall Number
    Z-1793-2026
    Event Number
    98374
    Firm
    Spacelabs Healthcare, Inc.
    FEI Number
    3010157426
    Product Code
    DSI
    Status
    Open, Classified
    Root Cause
    Component change control
    Initiated
    February 27, 2026
    Posted
    April 7, 2026
    Address
    35301 Se Center St, Snoqualmie, WA, 98065-9216

    Description

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    Reason

    Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO measurement not automatically excluded, which may result in inaccurate readings, or the need of additional readings, which may lead to delayed care and/or fluid overload.

    Action

    On 2/27/2026, correction notices were emailed to customers who were asked to do the following: 1. Notify all relevant employees within your organization. If products were further distributed, please forward the notice to these sites/customers. 2. Complete and return the acknowledgement form via email to: [email protected] 3. Instruct staff who utilize the cardiac output feature to use the "Manual" mode, or use a non-impacted module in its place (if available) until the impacted module has been corrected. 4. Contact your local Spacelabs Healthcare service and support representative to schedule your device correction as soon as possible. Firm's Support Contact: Phone: 1-800-522-7025 Email: [email protected] Website: https://spacelabshealthcare.com/support/

    Distribution

    Worldwide - US Nationwide distribution including in the states of NY, NJ, AL, OK, IA, MT, WY, MN, TX, WI, PA, WA, OR, MI, CA, SC, ID, FL, MS, KS, SD, LA, OH, MO, NH, GA, MD, TN, AZ, PR and the countries of TAIWAN, CANADA, KUWAIT, FRANCE, SAUDI ARABIA, POLAND, PAKISTAN, MEXICO, ARGENTINA, PANAMA.

    Quantity

    1790