BEUDAMED
    FDA Recall Terminated

    Linear Array Transducer Type: 8809

    Recall: Z-0271-05 · Initiated November 12, 2004

    Recall

    Recall Number
    Z-0271-05
    Event Number
    30410
    Firm
    B & K Medical Systems Inc.
    FEI Number
    1523841
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 12, 2004
    Posted
    December 2, 2004
    Terminated
    January 18, 2005
    Address
    267 Boston Rd, North Billerica, MA, 01862-2310

    Description

    Linear Array Transducer Type: 8809

    Reason

    Defect at probe tip may effect sterilization and electrical safety

    Action

    BK Medical Wilmington, MA notified accounts by letter dated 11/ 12 /04 via UPS Overnight.. Accounts are requested to return the unit.

    Distribution

    CA, CO, CT, FL, LA, GA, NJ, NY, VA, VT

    Quantity

    17 units