Recall Z-2339-2008 ยท ITI Wheelchair, Powered
Sunrise Medical Inc
Sunrise Medical Quickie Groove Power Wheelchair with Transit option The product is a powered wheelchair for human use.
| Date | Sep 23, 2008 (initiated Nov 13, 2006) |
| Status | Terminated |
| Reason | Rear bolts holding the frame in place may shear and the front bolts may potentially come off the posts, resulting in partial or full seat detachment in a sudden stop or crash. |
| Root cause | Device Design |
| Action | Initial phone contacts began on November 13, 2006. Letters were also mailed. The letter informed the customer of the problem and provided interim steps to take, until an transit upgrade kit is installed. Response cards will be tracked to measure response rate and assure receipt of notice. Contact Sunrise Medical at 1-800-456-8168 for assistance. |
| Quantity | 36 units |
| Distribution | Worldwide: US, Canada, New Zealand and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060531 | QUICKIE RHYTHM & GROOVE SERIES POWER WHEELCHAIRS W/QUICKIE DELPHI CONTROLS Sunrise Medical, Mar 17, 2006 |