Retiro De Equipo (Recall) de Device Recall Superstand standup wheelchair

Recall

67076

Class 2

Z-0993-2014

2013-05-16

2014-02-19

Terminated

United States

2014-06-25

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124663

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.

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.