BEUDAMED
    FDA Enforcement Class II Terminated

    Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.

    Recall: Z-2035-2019 · Reported July 31, 2019

    Enforcement

    Recall Number
    Z-2035-2019
    Event ID
    83220
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spacelabs Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 31, 2019
    Initiation Date
    January 28, 2019
    Classification Date
    July 22, 2019
    Termination Date
    February 24, 2022
    Address
    35301 Se Center St, N/A, Snoqualmie, WA, 98065-9216, United States

    Description

    Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.

    Reason

    Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.

    Code Info

    All affected Smart Disclosure installations with software versions 5.00, 5.01, 5.02, or 5.03, UDI 10841522123580.

    Distribution

    Distribution was nationwide. There was also government and military distribution. Foreign distribution was made to Argentina, Bahrain, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Costa Rica, Czech Republic, France, Hong Kong, India, Indonesia, Italy, Kuwait, Malaysia, Mexico, Netherlands, Pakistan, Palestine, Panama, Philippines, Poland, Qatar, Romania, Saudi Arabia, Spain, Switzerland, Taiwan, Trinidad and Tobago, Tunisia, Turkey, UAE, United Kingdom, and Viet Nam.

    Quantity

    295 customer sites have the affected software versions