Recall Z-0993-2014 ยท IPL Wheelchair, Standup
The Standing Company
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.
| Date | Feb 19, 2014 (initiated May 16, 13) |
| Status | Terminated |
| 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. |
| Root cause | 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 f |
| Quantity | approximately 119 |
| Distribution | Nationwide Distribution including AL, CA, DE, IA, IL , IN, KS, KY, MI, MO, NJ, OH, OK, TX, WA, WI,and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032101 | POWERSTAND STAND-UP WHEELCHAIR The Standing Co., Inc., Jan 22, 2004 |