BEUDAMED
    FDA Recall Terminated

    Video Cystoscope models ECY-1570 and ECY-1570K

    Recall: Z-0615-2018 · Initiated July 13, 2017

    Recall

    Recall Number
    Z-0615-2018
    Event Number
    79131
    Firm
    Pentax of America Inc
    FEI Number
    1000080301
    Product Code
    FAJ
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    July 13, 2017
    Terminated
    July 22, 2019
    Address
    3 Paragon Dr, Montvale, NJ, 07645-1782

    Description

    Video Cystoscope models ECY-1570 and ECY-1570K

    Reason

    The video cytoscopes lack 510(k) premarket notification clearance.

    Action

    Customer Instructions: Customers should inspect their stock of PENTAX Medical ECY-1570 and ECY-1570K video cystoscopes, quarantine them, and discontinue use of these products. If you have sold and distributed these products, please provide a copy of the notice and response form to the new owners. Enclosed with this letter is a customer response form. The form identifies the affected endoscopes (model and serial numbers) which have been sold to your facility. The attached form should be completed and returned to PENTAX Medical. Contact Information: If you have any questions regarding this action, please feel free to contact PENTAX Medical Customer Service. Tel: 800-431-5880 (8:30 AM 5:00 PM, Monday Friday, EST) Fax: 201-799-4063 (alternate 201-391-4189) Email: [email protected]

    Distribution

    Distributed in 8 states: CA, IL, MD, MI, ND, NH, NY, SD, and Guam.

    Quantity

    24