BEUDAMED
    FDA Recall Open, Classified

    TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP

    Recall: Z-0557-2024 · Initiated September 28, 2023

    Recall

    Recall Number
    Z-0557-2024
    Event Number
    93433
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    EOQ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    September 28, 2023
    Posted
    December 14, 2023
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP

    Reason

    Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.

    Action

    An Urgent Medical Device notification dated November 1, 2023 issued via UPS Ground. The notice advises customers to examine inventory for affected serial numbers and quarantine affected product. Contact Olympus Customer Solutions Team (1-800-848-9024, option 3) to arrange for for return. Olympus will inspect and repair if necessary. Customers are to forward notice to any facility affected product may have been transferred to. Olympus requests that you acknowledge receipt of this letter with [email protected].

    Distribution

    Worldwide - US Nationwide distribution in the states of AK, AL, AZ, CA, GA, IL, IN, MA, MD, MI, NC, NJ, OH, TX, UT, VA, WA, WV & AP (Armed Forces Pacific) and the countries of OUS: EMEA, Japan and Australia.

    Quantity

    75