BEUDAMED
    FDA Recall Terminated

    Solar 9500 Information Monitor with software version 3A.

    Recall: Z-0250-04 · Initiated November 10, 2003

    Recall

    Recall Number
    Z-0250-04
    Event Number
    27811
    Firm
    General Electric Medical Systems Information Technology
    FEI Number
    2124823
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 10, 2003
    Posted
    December 18, 2003
    Terminated
    November 23, 2005
    Address
    8200 W Tower Ave, Milwaukee, WI, 53223-3219

    Description

    Solar 9500 Information Monitor with software version 3A.

    Reason

    Software gives inaccurate readings when transferring TRAM module from Solar 9500 to other Solar monitoring systems without discharging TRAM first.

    Action

    A letter dated November 10, 2003 was sent to the consignees. The letter recommended certain actions to avoid the problems and provided options for the software to be updated.

    Distribution

    The product was distributed to consignees located nationwide in the United States and worldwide.

    Quantity

    maximum 648 Solar 9500s with Version 3A software (297 Solar 9500 Vers. 3A software were manufactured plus 131 software update kits to update multiple)