BEUDAMED
    FDA Recall Open, Classified

    Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources. Includes the following Model Numbers: 1. Model Number: 2090255-001; 2. Model Number: 2088026-723; 3. Model Number: 2102676-001; 4. Model Number: 2104867-044.

    Recall: Z-2503-2021 · Initiated August 6, 2021

    Recall

    Recall Number
    Z-2503-2021
    Event Number
    88526
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    LLZ
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    August 6, 2021
    Posted
    September 22, 2021
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources. Includes the following Model Numbers: 1. Model Number: 2090255-001; 2. Model Number: 2088026-723; 3. Model Number: 2102676-001; 4. Model Number: 2104867-044.

    Reason

    Image acquisition failures and synchronization failure with the Centricity Enterprise Archive

    Action

    This issue will be resolved by sending an Urgent Medical Device Correction letter to customers with affected software versions on August 06, 2021. This letter informs customers of the issues and provides safety instructions. GE Healthcare will correct the issue through a product change. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

    Distribution

    AK, AZ, CA, CO, DE, FL, GA, IA, IN, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, UT, WA, WI, WV and WY. Austria, Brazil, Canada, France, Germany, Ghana, India, Ireland, Israel, Italy, Kuwait, Netherlands, Panama, Poland, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, United Kingdom and Uruguay.

    Quantity

    462 (279 US; 183 OUS)