FDAFDA · Alimentos y medicamentos·N.º oficial Z-0993-2014
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.
Publicado el 26 de febrero de 2014 · Inicio del retiro: 16 de mayo de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- The Standing Company
- Distribuidor
- Nationwide Distribution including AL, CA, DE, IA, IL , IN, KS, KY, MI, MO, NJ, OH, OK, TX, WA, WI,and WV.
- Lote
- 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.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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