BEUDAMED
    FDA Recall Terminated

    Deikos A+

    Recall: Z-0944-04 · Initiated April 29, 2004

    Recall

    Recall Number
    Z-0944-04
    Event Number
    28982
    Firm
    Biotronik Inc
    FEI Number
    1028232
    Product Code
    LWS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 29, 2004
    Posted
    July 20, 2004
    Terminated
    April 21, 2006
    Address
    6024 Jean Rd, Lake Oswego, OR, 97035-5308

    Description

    Deikos A+

    Reason

    Potential for device to not deliver full amount of energy

    Action

    On 4/29/04 the firm issued 'Dear Doctor' letters to the physicians. The letter instructs the physician to schedule an immediate follow-up with all affected patients to determine if their devices are being impacted by the passivation buildup and to determine if device replacement is indicated.

    Distribution

    Devices were distributed to physicians and medical centers throughout the U.S. The firm does not distribute internationally.

    Quantity

    6