BEUDAMED
    FDA Recall Terminated

    Octopus 900 Perimeter, EyeSuite Perimetry version i4.000 (Flash v. 2.1.4 & 2.1.5), Model Number: Octopus 900, Distributed by: Haag-Streit USA, Inc., 3535 Kings Mills Rd., Mason, OH 45040 Product Usage: The OCTOPUS 900 Perimeter is designed for the examination, analysis and documentation of the field of sight, especially the light difference sensitivity and other functions of the human eye.

    Recall: Z-0638-2012 · Initiated November 14, 2011

    Recall

    Recall Number
    Z-0638-2012
    Event Number
    60631
    Firm
    Haag-Streit USA Inc
    FEI Number
    1000136533
    Product Code
    HJB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 14, 2011
    Posted
    January 11, 2012
    Terminated
    June 26, 2014
    Address
    3535 Kings Mills Rd, Mason, OH, 45040

    Description

    Octopus 900 Perimeter, EyeSuite Perimetry version i4.000 (Flash v. 2.1.4 & 2.1.5), Model Number: Octopus 900, Distributed by: Haag-Streit USA, Inc., 3535 Kings Mills Rd., Mason, OH 45040 Product Usage: The OCTOPUS 900 Perimeter is designed for the examination, analysis and documentation of the field of sight, especially the light difference sensitivity and other functions of the human eye.

    Reason

    Currently there is a possibility, at the start of the perimetry examination, for the background illumination of the cupola not to turn on. If no illumination of cupola occurs, data obtained from the examination could provide the doctor with results that would appear to be better than actual.

    Action

    Haag-Streit USA Inc sent an Urgent Field Safety Notice letter dated November 11, 2011 to their customers. The letter identified the product, the problem, and the actions to be taken. Customers were instructed to check their unit and if needed upgrade their unit with the new software provided. Customers were advised to complete and return the Software Update Verification Form included. Customers who had distributed the affected product outside of their facility were instructed to immediately notify their customers of the recall.

    Distribution

    Worldwide Distribution - USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA and WA and the country of Mexico.

    Quantity

    158 Units