BEUDAMED
    FDA Enforcement Class II Ongoing

    Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.

    Recall: Z-2502-2021 · Reported September 29, 2021

    Enforcement

    Recall Number
    Z-2502-2021
    Event ID
    88526
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 29, 2021
    Initiation Date
    August 6, 2021
    Classification Date
    September 22, 2021
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.

    Reason

    Image acquisition failures and synchronization failure with the Centricity Enterprise Archive

    Code Info

    2068177-001 (Centricity PACS-IW with Universal Viewer software versions 5.0.x with PACS-IW foundation) System ID: 083055248481416, 1-121967267, 1-429329281, DGC19607785, HC3062UV01, HCIT1401012UW, HCIT4331279UV, PACS-IW-127, PACS-IW-219, PACS-IW-2770, PACS-IW-323, PACS-IW-421, RICHMONDU14767331, RICHMONDU15531177N1, X1347906 / X1347909, X1347906 / X1347909, YP315021, ZA2412PAC21 and ZA2533PAC1

    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

    392 (219 US; 173 OUS) all products