BEUDAMED
    FDA Recall 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 · Initiated December 12, 2016

    Recall

    Recall Number
    Z-1075-2017
    Event Number
    76089
    Firm
    Pentax of America Inc
    FEI Number
    1000080301
    Product Code
    EQL
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    December 12, 2016
    Terminated
    March 22, 2019
    Address
    3 Paragon Dr, Montvale, NJ, 07645-1782

    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.

    Action

    The firm, Pentax Medical, sent an "U.S. URGENT FIELD CORRECTION" letter and a Return Response form dated December 12, 2016 to their affected customers via USPS Certified Mail. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that all users read and carefully follow the revised IFU in order to properly operate and reprocess the affected product; contact your PENTAX Medical sales representative to arrange for training regarding the new procedures, and complete and return the FIELD CORRECTION RESPONSE FORM via fax to: PENTAX Recall Coordinator at 201-799-4063 (alternate 201-391-4189) or email a pdf copy to [email protected] even if you no longer possess the product. If you have any questions regarding this action, please feel free to contact us at: 800-431-5880 (8:30 AM-5:00 PM, Monday-Friday, EST) or email: [email protected].

    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))