BEUDAMED
    FDA Enforcement Class II Terminated

    Superstand stand-up wheelchair HPS-2 A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.

    Recall: Z-0993-2014 · Reported February 26, 2014

    Enforcement

    Recall Number
    Z-0993-2014
    Event ID
    67076
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Standing Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 26, 2014
    Initiation Date
    May 16, 2013
    Classification Date
    February 19, 2014
    Termination Date
    June 25, 2014
    Address
    5848 Dixie Hwy, Saginaw, MI, 48601-5967, United States

    Description

    Superstand stand-up wheelchair HPS-2 A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.

    Reason

    Power Superstand Standing Wheel chair, flex shaft (the flexible wand which supports the joystick control module) may fracture if it is bent repeatedly and /or beyond 90 degrees. A newly designed Flexshaft which corrects this problem is available at no charge.

    Code Info

    Serial No: 1306, 1313, 1342, 1349, 1362, 1358, 1359, 1392, 1391, 1406, 1402, 1407, 1426, 1441, 1451, 1018, 1453, 1399, 1523, 1477, 1480, 1482, 1497, 1494, 1505, 1516, 1533, 1537, 1536, 1535, 1542, 1544, 1549, 1543, 1550, 1562, 1563, 1566, 1580, 1572, 1573, 1574, 1571, 1578, 1583, 1641, 1593, 1591, 1592, 1599, 1604, 1600, 1615, 1616, 1614, 1622, 1631, 1637, 1643, 1635, 1640, 1634, 1648, 1666, 1652, 1657, 1663, 1664, 1676, 1689, 1665, 1683, 1691, 1688, 1701, 1703, 1711, 1698, 1712, 1719, 1728, 1731, 1726, 1740, 2165, 2172, 2175, 2177, 2257, 2182, 2197, 2205, 2258, 2259, 2262, 2270, 2283, 2279, 2281, 2298, 2306, 2310, 2312, 2330, 2334, 2503, 2515, 2328, 2514, 2523, 2525, 2550, 2561, 2568, 2581, 2573, 1684, and 1427.

    Distribution

    Nationwide Distribution including AL, CA, DE, IA, IL , IN, KS, KY, MI, MO, NJ, OH, OK, TX, WA, WI,and WV.

    Quantity

    approximately 119