BEUDAMED
    FDA Recall Terminated

    Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053.

    Recall: Z-0305-06 · Initiated September 16, 2005

    Recall

    Recall Number
    Z-0305-06
    Event Number
    33936
    Firm
    Witt Biomedical Corporation
    FEI Number
    1051786
    Product Code
    MWI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 16, 2005
    Posted
    December 23, 2005
    Terminated
    July 11, 2012
    Address
    305 North Drive, Melbourne, FL, 32934-9201

    Description

    Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053.

    Reason

    Customer complained that a boom monitor came off the boom. No patient or user injury was associated with the incident.

    Action

    Consignees will be notified of recall by phone, the firm will use a phone script.

    Distribution

    Products were distributed to approximately 672 medical facilities throughout the United States.

    Quantity

    1541