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U.S. Department of Health and Human Services

Class 2 Device Recall Superstand standup wheelchair

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  Class 2 Device Recall Superstand standup wheelchair see related information
Date Initiated by Firm May 16, 0013
Date Posted February 19, 2014
Recall Status1 Terminated 3 on June 25, 2014
Recall Number Z-0993-2014
Recall Event ID 67076
510(K)Number K032101  
Product Classification Wheelchair, standup - Product Code IPL
Product 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.
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.
Recalling Firm/
Manufacturer		 The Standing Company
5848 Dixie Hwy
Saginaw MI 48601-5967
For Additional Information Contact Chris Moran
989-746-9100
Manufacturer 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.
FDA Determined
Cause 2		 Component design/selection
Action The Standing Company sent an Urgent Medical Device Field Correction/Part Recall dated February 6, 2014, to all affected customers. The Urgent Recall notification identified the Flexshaft holding the control joystick on all Power Standing Wheelchairs were being replaced after investigation of complaints found the flexshaft could break because the inner spring of the shaft had failed, although the outer core remained intact. The notice explained how the failure would appear and that the break could happen without warning. The notice explained that the break would not cause the flexshaft to fall off the chair, or hit the ground and the chair could still be mobilized by having the user lean over and pick up the joystick. The notice warned customers not to over bend the flexshaft until replacement was performed. Consignees were asked to call 1-800-STANDING ( 1 800-782-6346) immediately if their wheelchair needed immediate flexshaft replacement. The notice stated that consignees would be contacted to set up a time and date to replace their current flexshaft, at no charge. Consignees were asked to complete and return the response form with customer contact information to Standing Wheelchair Company 5848 Dixie Hwy, Saginaw, MI 48601; Fax (989) 746-9185 or E-mail mail@thestandingcompany.com. Questions and Concerns should be addressed to Customer Service Manager Chris Moran, 1 800 782-6346. For questions regarding this recall call 989-746-9100.
Quantity in Commerce approximately 119
Distribution Nationwide Distribution including AL, CA, DE, IA, IL , IN, KS, KY, MI, MO, NJ, OH, OK, TX, WA, WI,and WV.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IPL and Original Applicant = THE STANDING CO., INC.
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