Recall Z-0518-06 ยท ITI Wheelchair, Powered
Sunrise Medical Inc
Quickie brand Freestyle M11 & F11, C. G. Tilt, Powered Wheelchair; Product is manufactured and distributed by Sunrise Medical, 2842 Business Park Ave., Fresno, CA 93727
| Date | Feb 14, 2006 (initiated Nov 15, 2005) |
| Status | Terminated |
| Reason | While operating the powered wheelchair beyond a specified angle of recline, the wheelchair can travel at an unsafe speed when in this position. |
| Root cause | Other |
| Action | On November 9, 2005, the firm contacted its consignees via telephone, which was followed up by a mailing, to alert them of the situation. The firm is making arrangements to conduct the service correction at users'' residence. All appointmens are scheduled to be completed by December 15, 2005. |
| Quantity | 5 units |
| Distribution | All 5 units were distributed to direct consignees, in CA, MA, NC, and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031289 | QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424 Sunrise Medical, Inc., May 9, 2003 |