BEUDAMED
    FDA Enforcement Class II Terminated

    PINPOINT Endoscopic Fluorescence Imaging System

    Recall: Z-1032-2016 · Reported March 9, 2016

    Enforcement

    Recall Number
    Z-1032-2016
    Event ID
    73225
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Novadaq Technologies Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 9, 2016
    Initiation Date
    January 29, 2016
    Classification Date
    March 2, 2016
    Termination Date
    November 3, 2016
    Address
    8329 Eastlake Dr Unit 101, N/A, Burnaby, N/A, N/A, Canada

    Description

    PINPOINT Endoscopic Fluorescence Imaging System

    Reason

    It has been determined that the PINPOINT Operator's Manual does not contain validated parameters for gravity-cycle autoclave sterilization of the PINPOINT laparoscopes and light guide cable in the reprocessing tray.

    Code Info

    Rev. J, Rev. K, Rev. L and Rev. M Model Number : PC9000

    Distribution

    Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Bangladesh, Canada, Hong Kong, India, and Israel.

    Quantity

    110 units