Superstand stand-up wheelchair HPS-2 A standup wheelchair is a device with wheels that is int...

FDA Device Recall #Z-0993-2014 — Class II — May 16, 2013

Recall Summary

Recall Number Z-0993-2014
Classification Class II — Moderate risk
Date Initiated May 16, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm The Standing Company
Location Saginaw, MI
Product Type Devices
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.

Lot / 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.

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.