BEUDAMED
    FDA Recall Terminated

    Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.

    Recall: Z-2411-2012 · Initiated August 17, 2012

    Recall

    Recall Number
    Z-2411-2012
    Event Number
    63011
    Firm
    Haag-Streit USA Inc
    FEI Number
    1000136533
    Product Code
    HPT
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    August 17, 2012
    Posted
    September 20, 2012
    Terminated
    May 29, 2015
    Address
    3535 Kings Mills Rd, Mason, OH, 45040

    Description

    Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.

    Reason

    The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101.

    Action

    The firm, HAAG-STREIT USA, Inc., sent a "Field Safety Notice 2012-01/01" dated August 10, 2012 via certified mail or onsite visit to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to make all users of the product and relevant personnel aware of this Field Safety Notice; forward a copy to third parties, if affected product has been passed on; keep this notice at least until the completion of the corrective measure, and complete and return the enclosed Confirmation of Receipt Form via fax to: 513-229-3867 or scanned and emailed to : [email protected]. If you have any questions, call 513-336-7255.

    Distribution

    Worldwide distribution: USA (nationwide) including states of: AR, CA, CT, FL, GA, IA, IL, LA, MA, MI, MN, MS, NJ, NV, NY, OH, OR, PA, SC, SD, WA, WI, and WV; and to the countries of Jamaica, Puerto Rico, and Mexico.

    Quantity

    64 units