BEUDAMED
    FDA Enforcement Class II Terminated

    Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.

    Recall: Z-1075-2017 · Reported February 1, 2017

    Enforcement

    Recall Number
    Z-1075-2017
    Event ID
    76089
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pentax of America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 1, 2017
    Initiation Date
    December 12, 2016
    Classification Date
    January 23, 2017
    Termination Date
    March 22, 2019
    Address
    3 Paragon Dr, N/A, Montvale, NJ, 07645-1782, United States

    Description

    Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.

    Reason

    Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108.

    Code Info

    Model #'s 9106 and 9108

    Distribution

    Worldwide Distribution-US (nationwide) and countries of: Albania, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Oman, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Trinidad, Turkey, United Arab Emirates, and United Kingdom.

    Quantity

    2,056 (1,545 (US) and 511 (OUS))