BEUDAMED
    FDA Enforcement Class II Terminated

    Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V

    Recall: Z-1894-2017 · Reported May 10, 2017

    Enforcement

    Recall Number
    Z-1894-2017
    Event ID
    77075
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sonesta Medical Ab
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 10, 2017
    Initiation Date
    March 8, 2017
    Classification Date
    April 28, 2017
    Termination Date
    August 20, 2019
    Address
    Adolfsbergsvagen 31, Bromma, N/A, Sweden

    Description

    Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V

    Reason

    The user / service manual for the Sonesta S2 Chair contain wrong information concerning the maximum patient weight.

    Code Info

    12-00001-110V 12-00011-110V 23-00002-220V (Demo Product) 12-00002-110V 12-00012-110V 23-00001-220V 12-00003-110V 12-00013-110V 23-00003-220V 12-00004- 110V 12-00014-110V 23-00004-220V 12-00005-110V 12-00015-110V 23-00005-220V 12-00006-110V 12-20001-110V 23-00006-220V 12-00007-110V 12-20002-110V 23-00009-220V 12-00008-110V 12-20003-110V 23-00020-220V 12-00009-110V 12-20004 -110V 23-20001-220V 12-00010-110V 23-20002-220V

    Distribution

    Worldwide Distribution - US Distribution to the state of : MA., and to the countries of : Canada, Netherlands, Dubai, Taiwan, Lebanon, Italy

    Quantity

    28 devices