BEUDAMED
    FDA Recall Terminated

    Pentax Video Colonoscope Model: EC34-i10L

    Recall: Z-1267-2020 · Initiated January 3, 2020

    Recall

    Recall Number
    Z-1267-2020
    Event Number
    84735
    Firm
    Pentax of America Inc
    FEI Number
    1000080301
    Product Code
    FDF
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    January 3, 2020
    Terminated
    January 26, 2021
    Address
    3 Paragon Dr, Montvale, NJ, 07645-1782

    Description

    Pentax Video Colonoscope Model: EC34-i10L

    Reason

    Distributed in the USA without an approved 510K

    Action

    Pentax Medical contacted US Affected Customers by telephone to inform them of the pending action and to advise they quarantine the affected products Pentax issued URGENT MEDICAL DEVICE CORRECTIONAND REMOVAL Letter via UPS dated 1/3/20 states: reason for recall, health risk and action to take: Please quarantine the units your facility owns, complete the response form, and return it to PENTAX Medical using the e-mail address or fax number listed below. Upon return of the response form, PENTAX will contact your facility to arrange the return of the affected units. Loaner units will be supplied until this issue is resolved. Question contact: 1-800-431-5880 (8:30 AM 5:00 PM, Monday Friday, EST) Fax: 201-799-4063 (alternate 201-391-4189) Email: [email protected]

    Distribution

    NC, MA