BEUDAMED
    FDA Recall Terminated

    Nellcor brand Pulse Oximeter, model N-395, Made in Ireland; Distributed by Tyco Healthcare Group, LP, Nellcor Puritan Bennett, Inc., Pleasanton, CA 94588 U.S.A.

    Recall: Z-0665-05 · Initiated October 18, 2004

    Recall

    Recall Number
    Z-0665-05
    Event Number
    31271
    Firm
    Nellcor Puritan Bennett
    FEI Number
    2936999
    Product Code
    DQA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 18, 2004
    Posted
    March 30, 2005
    Terminated
    May 15, 2006
    Address
    4280 Hacienda Dr, Pleasanton, CA, 94588-2719

    Description

    Nellcor brand Pulse Oximeter, model N-395, Made in Ireland; Distributed by Tyco Healthcare Group, LP, Nellcor Puritan Bennett, Inc., Pleasanton, CA 94588 U.S.A.

    Reason

    The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.

    Action

    Customers of record were notified of the advisory by letter sent via US Mail on October 18, 2004, via certified mail. A second letter was sent on December 9, 2004, advising customers that upgrades would be available. Upgrades would be available via returns to the firm''s service center, upgrade kits and speaker replacements via self-installation, and a third party service provider.

    Distribution

    There are 2,950 Direct US and US territory Customers. Product shave also been distributed to Canada, Europe, Japan, Latin America and Australia.

    Quantity

    5,344 units