Events

Recall of Device Recall Superstand standup wheelchair

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by The Standing Company.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67076
  • Event Risk Class
    Class 2
  • Event Number
    Z-0993-2014
  • Event Initiated Date
    2013-05-16
  • Event Date Posted
    2014-02-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124663
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Wheelchair, standup - Product Code IPL
  • 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.
  • 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.

Device

Device Recall Superstand standup wheelchair
  • Model / Serial
    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.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AL, CA, DE, IA, IL , IN, KS, KY, MI, MO, NJ, OH, OK, TX, WA, WI,and WV.
  • 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.
  • Manufacturer
    The Standing Company

Manufacturer

The Standing Company
  • Manufacturer Address
    The Standing Company, 5848 Dixie Hwy, Saginaw MI 48601-5967
  • Manufacturer Parent Company (2017)
    The Standing Company
  • Source
    USFDA