BEUDAMED
    FDA Recall Terminated

    MilCAM Recon III, Family of IR Imagers that incorporates a Class IIIb infared laser pointer

    Recall: Z-1223-2009 · Initiated March 10, 2009

    Recall

    Recall Number
    Z-1223-2009
    Event Number
    51867
    Firm
    Flir Systems, Inc.
    FEI Number
    1220474
    Product Code
    REQ
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    March 10, 2009
    Posted
    September 25, 2009
    Terminated
    May 28, 2015
    Address
    25 ESQUIRE RD, North Billerica, MA, 01862-2501

    Description

    MilCAM Recon III, Family of IR Imagers that incorporates a Class IIIb infared laser pointer

    Reason

    MilCAM Recon III models were sold to non-DoD customers prior to certification and reporting as required in Title 21 of the Code of Federal Regulations. Conditions of sale were not stated in variance approval letters issued for similar laser products.

    Action

    FLIR Systems notified direct account by letter of the Corrective Action Plan and updated certification label that references CDRH issued variance and instructions on how to install it.

    Distribution

    Nationwide Distribution -- Washington, D.C.

    Quantity

    58