BEUDAMED
    FDA Recall Terminated

    GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4 and 2380179 containing Proteus Operator Console model# 2259976.

    Recall: Z-1087-2007 · Initiated May 31, 2006

    Recall

    Recall Number
    Z-1087-2007
    Event Number
    38633
    Firm
    General Electric Med Systems LLC
    FEI Number
    2126677
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 31, 2006
    Posted
    September 25, 2007
    Terminated
    December 11, 2007
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4 and 2380179 containing Proteus Operator Console model# 2259976.

    Reason

    Labeling; failure to properly label per 21 CFR 1010.2 and 1010.3 -The Operator Console of the Proteus XR/a General Purpose Radiographic Systems were not properly labeled.

    Action

    Consignees were notified of the problem by a visit. To address the Proteus System shipped to the field, a Field Modification (FMI) was created to correct units in the field.

    Distribution

    Nationwide; including states of WA,KS, CO, NM, NC, FL, MT, AZ, TX, IL, NY, MD, and GA

    Quantity

    22 units