BEUDAMED
    FDA Recall Terminated

    PINPOINT Endoscopic Fluorescence Imaging System

    Recall: Z-1032-2016 · Initiated January 29, 2016

    Recall

    Recall Number
    Z-1032-2016
    Event Number
    73225
    Firm
    Novadaq Technologies Inc.
    FEI Number
    3012345110
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    January 29, 2016
    Terminated
    November 3, 2016
    Address
    8329 Eastlake Dr, Unit 101, Burnaby 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.

    Action

    Novadaq sent an Urgent Device Correction letter dated February 2, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Recipients of this notice have received shipments that include the inaccurate Operator's Manual. Please follow these instructions: 1. Discard any old PINPOINT Operator's Manuals Rev J through M. 2. Accept and review the new PINPOINT Operator's Manual (Rev N). 3. Complete and sign the enclosed "Acknowledgement of Receipt" form, scan it and email to PI [email protected]. Any questions or concerns may also be sent to this address. For further questions, please call 1-(844) 668-2327, ( Select Option # 1)

    Distribution

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

    Quantity

    110 units