BEUDAMED
    FDA Recall Terminated

    Ellex, Eye Cubed, I 3 System-ABD Ultrasound Version 3.0 with Software Version 3.0 and Biometry A-scan modality, Ellex Innovative Imaging, Sacramento, CA 95827

    Recall: Z-0148-2008 · Initiated September 25, 2007

    Recall

    Recall Number
    Z-0148-2008
    Event Number
    45398
    Firm
    Ellex Inc.
    FEI Number
    1000123964
    Product Code
    IYO
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 25, 2007
    Posted
    December 28, 2007
    Terminated
    September 8, 2008
    Address
    9940 Business Park Dr, Ste 155, Sacramento, CA, 95827-1713

    Description

    Ellex, Eye Cubed, I 3 System-ABD Ultrasound Version 3.0 with Software Version 3.0 and Biometry A-scan modality, Ellex Innovative Imaging, Sacramento, CA 95827

    Reason

    Incorrect IOL calculations: software behavior with Version 3.0 Eye Cubed Ultrasound systems running Biometry A-scan enabled Version 3.0.0 software can cause incorrect IOL calculations.

    Action

    A Global Customer Service Bulletin (GCSB)-Urgent Notification of Software Correction was issued on 25 September 2007, which provided short term workaround directions pending a free software undate promised in the near future.

    Distribution

    Worldwide; including Canada and Mexico. U.S.A. distribution included states of AL, AZ, CA, CT, FL, GA, IL, MA, ME, MI, MN, NC, NE, NJ, NM, NY, OH, OR, PA, SC, TN, and TX.

    Quantity

    59