BEUDAMED
    FDA Recall Terminated

    Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system

    Recall: Z-0012-2022 · Initiated August 12, 2021

    Recall

    Recall Number
    Z-0012-2022
    Event Number
    88595
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 12, 2021
    Posted
    October 2, 2021
    Terminated
    August 22, 2024
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system

    Reason

    A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA).

    Action

    This issue will be resolved by sending an Urgent Medical Device Correction letter to customers with affected software versions on August 13, 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

    AR, IL, ME, MS, NE, NJ, NY, and TN Belgium, Canada, Costa Rica, France, Germany, India, Japan, Korea, Kuwait, Saudi Arabia, Singapore, Switzerland, Switzerland, Turkey and United Kingdom

    Quantity

    49