BEUDAMED
    FDA Recall Open, Classified

    TASE 500 Imaging systems

    Recall: Z-1784-2019 · Initiated January 29, 2019

    Recall

    Recall Number
    Z-1784-2019
    Event Number
    82988
    Firm
    COLLINS AEROSPACE
    FEI Number
    3021214229
    Product Code
    RET
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    January 29, 2019
    Address
    9 Technology Park Dr, Westford, MA, 01886-3141

    Description

    TASE 500 Imaging systems

    Reason

    the Nominal Ocular Hazard Distance (NOHD) associated with a Class lllb alignment laser utilized in its TASE family of imaging systems has been miscalculated.

    Action

    Collins Aerospace sent a customer notification letter to affected customers,. The letter identified the affected product problem and actions to be taken. For questions contact Customer Support Team at [email protected]

    Distribution

    US Nationwide Distribution

    Quantity

    433 in total