Recall Z-0831-2011 ยท IOR Wheelchair, Mechanical
Sunrise Medical Inc
Manual Wheelchairs with Transit System Option, Model: Quickie LXI (EILXI), Product is manufactured and distributed by Sunrise Medical, Inc. Fresno, CA Intended to provide mobility to persons restricted to a sitting position and are unable to transfer from their wheelchairs when traveling in motor vehicles, the wheelchair must serve as a vehicle seat.
| Date | Dec 28, 2010 (initiated Feb 2, 2009) |
| Status | Terminated |
| Reason | The stabilizer bar was inadvertently omitted during the manufacturing process. |
| Root cause | Process change control |
| Action | An Urgent: Medical Device Correction letter, dated February 2009, with certified return receipt was sent to customers in the United States; Canadian consignees were notified via e-mail. The letter identified the affected product and the reason for the recall. The letters asked customers to contact their Quickie dealer to make arrangements to have their device wheelchair corrected at no charge and to also verify their wheelchair serial number on the form. Questions should be directed towards their dealer or Sunrise Medical at 800-456-8168. |
| Quantity | 23 |
| Distribution | Worldwide Distribution -- United States and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973673 | QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE RIGID SERIES Sunrise Medical, Inc., Nov 20, 1997 |