Z-0993-2014 Class II Terminated
FDA device recall Z-0993-2014 was initiated by The Standing Company on May 16, 2013 and is designated Class II. Reason for recall: 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 Flexs… The recall status is terminated (terminated June 25, 2014). Affected quantity: approximately 119.
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2014
- Initiation Date
- May 16, 2013
- Termination Date
- June 25, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- approximately 119
Product 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 for Recall
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.
Distribution Pattern
Nationwide Distribution including AL, CA, DE, IA, IL , IN, KS, KY, MI, MO, NJ, OH, OK, TX, WA, WI,and WV.
Code Information
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.