BEUDAMED
    FDA Recall Terminated

    GE Healthcare Proteus XR/a Radiographic X-ray System, Model Number 2259976; previously marketed as the Silhouette FC, GE Healthcare, Waukesha, WI 53188.

    Recall: Z-0842-2008 · Initiated November 1, 2007

    Recall

    Recall Number
    Z-0842-2008
    Event Number
    46859
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 1, 2007
    Posted
    June 10, 2008
    Terminated
    December 18, 2011
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Proteus XR/a Radiographic X-ray System, Model Number 2259976; previously marketed as the Silhouette FC, GE Healthcare, Waukesha, WI 53188.

    Reason

    The warning label that is required by 21 CFR 1020.30(j) was not on the control console of the Proteus XR/a Radiographic X-ray System, Model 2259976.

    Action

    GE issued a Field Modification Instruction to their field service representatives, released in December 2007, with instructions to replace the labels on the console with the appropriate labeling. Consignees will be visited by GE field service representatives beginning December 2007. All consignees will have the required labels affixed to their units by July 31, 2008.

    Distribution

    Worldwide Distribution, including USA, Canada, Mexico, France, Hong Kong, Italy, Korea, China, Poland, UK, New Zealand, Saudi Arabia, Taiwan, Turkey, and Australia.

    Quantity

    400 Units