BEUDAMED
    FDA Recall Terminated

    Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    Recall: Z-2278-2016 · Initiated April 6, 2016

    Recall

    Recall Number
    Z-2278-2016
    Event Number
    73985
    Firm
    Pentax Medical Company
    FEI Number
    1000080301
    Product Code
    FDF
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 6, 2016
    Posted
    July 23, 2016
    Terminated
    July 17, 2017
    Address
    3 Paragon Dr, Montvale, NJ, 07645-1782

    Description

    Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    Reason

    Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

    Action

    Pentax Medical sent an "Urgent Field Correction Letter and Response Form" dated April 6, 2016 via Certified Mail to their affected customers. The recall letter identified the product, problem and action to be taken by customer. The customer is asked to complete the response form even if the customers does not have any OS-H2/OS-H4 water bottles to discard. If customer needs assistance in completing the response form, they can contact their local sales representative. For questions regarding the recall, customers can contact Mr. Paul Silva, Pentax Americas Recall Coordinator at: (800) 431-5880 ext. 2064, from (8:30 am - 5:00 pm, Monday - Friday, EST), via fax: (201) 799-4063 or via email to: [email protected].

    Distribution

    US Nationwide Distribution

    Quantity

    10,074 units