Recall Z-1019-2015 ยท IOR Wheelchair, Mechanical
Sunrise Medical (US) LLC
Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1.
| Date | Jan 27, 2015 (initiated Dec 19, 2014) |
| Status | Terminated |
| Reason | There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs. |
| Root cause | Device Design |
| Action | Sunrise Medical sent an Urgent Medical Device Field Correction letters dated December 19, 2014 to the two affected distributors. The letter identified the affected product, problem and actions to be taken. For question contact Sunrise Medical Regulatory Affairs at either (559)294-2840. |
| Quantity | 3 |
| Distribution | Nationwide Distribution in the states of CO and ME. |
| 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 |