BEUDAMED
    FDA Recall Open, Classified

    Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012, f) 2049587-015, g) 2052829-001, h) Not applicable; Radiological Image Processing System

    Recall: Z-1502-2023 · Initiated March 28, 2023

    Recall

    Recall Number
    Z-1502-2023
    Event Number
    92062
    Firm
    GE Healthcare
    FEI Number
    3004526608
    Product Code
    LLZ
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    March 28, 2023
    Posted
    May 2, 2023
    Address
    500 W Monroe St, Chicago, IL, 60661-3671

    Description

    Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012, f) 2049587-015, g) 2052829-001, h) Not applicable; Radiological Image Processing System

    Reason

    GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.

    Action

    GE issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 03/28/2023 by mail (traceable means). The notice explained the issue and the risk, and provideed safety instructions for continued use of the device. GE HealthCare will address this issue through a software correction.

    Distribution

    Worldwide Distribution

    Quantity

    153 units