BEUDAMED
    FDA Recall Terminated

    Solar 8000M Patient Monitor with software versions 3A, 3B and 3C

    Recall: Z-0092-04 · Initiated June 14, 2002

    Recall

    Recall Number
    Z-0092-04
    Event Number
    27558
    Firm
    General Electric Medical Systems Information Technology
    FEI Number
    2124823
    Product Code
    DSI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 14, 2002
    Posted
    November 6, 2003
    Terminated
    November 8, 2005
    Address
    8200 W Tower Ave, Milwaukee, WI, 53223-3219

    Description

    Solar 8000M Patient Monitor with software versions 3A, 3B and 3C

    Reason

    Various user settings may change without an audible warning or visual indication. Examples of settings that may change are pacemaker detection which may turn from on to off, selected ECG leads for display, and selected gain settings for a selected waveform.

    Action

    A 'Patient Safety Alert' letter dated June 14, 2002 was sent to the consignees. The letter recommended certain actions to avoid the problems and stated that the firm''s field service team would contact the consignees to schedule a software revision to eliminate the problem.

    Distribution

    The devices were distributed nationwide in the United States and worldwide.

    Quantity

    2809 monitors and 238 software update kits