BEUDAMED
    FDA Recall Terminated

    MIRA CR4060 68 mm Finger Probe 68mm surf ace x 37mm Length Intended for the destruction of tumors.

    Recall: Z-1920-2010 · Initiated April 8, 2010

    Recall

    Recall Number
    Z-1920-2010
    Event Number
    55818
    Firm
    Mira, Inc.
    FEI Number
    1218813
    Product Code
    HPS
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    April 8, 2010
    Posted
    June 29, 2010
    Terminated
    August 8, 2016
    Address
    414 Quaker Hwy, Uxbridge, MA, 01569

    Description

    MIRA CR4060 68 mm Finger Probe 68mm surf ace x 37mm Length Intended for the destruction of tumors.

    Reason

    Devices distributed without an approved 510(k)

    Action

    Mira contacted accounts by email between 4/08/10-05/21/10 requesting return of inventory.

    Distribution

    Worldwide Distribution -- USA, including the state of NY and the countries of Israel and Italy.

    Quantity

    5 units