BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2035-2019 · Initiated January 28, 2019

    Recall

    Recall Number
    Z-2035-2019
    Event Number
    83220
    Firm
    Spacelabs Healthcare, Inc.
    FEI Number
    3010157426
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 28, 2019
    Terminated
    February 24, 2022
    Address
    35301 Se Center St, Snoqualmie, WA, 98065-9216

    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.

    Action

    The recalling firm began issuing customer letters on 1/28/2019 via priority service, return receipt requested, to all U.S. customers. The letter was translated, as necessary, and emailed on 2/4/2019 to the international subsidiaries and distributors. The firm identified 6 new customers (5 U.S. and 1 international) and the letter for the 5 new U.S. customers was issued 5/30/2019 via priority service, return receipt requested. The letter for the 1 new international customer was emailed on 5/28/2019.

    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