Recall Z-0453-2014 ยท IOR Wheelchair, Mechanical
Sunrise Medical (US) LLC
Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.
| Date | Dec 5, 2013 (initiated Nov 11, 2013) |
| Status | Terminated |
| Reason | There is a remote possibility for the plastic latch to deform over the lifetime of use. When this happens there is the possibility for the seat to become dislodged from the base. And when not using the positioning strap, there is a risk that the occupant could slide out of the seat and sustain injury. |
| Root cause | Nonconforming Material/Component |
| Action | Urgent Medical Device Field correction letters were sent to Sunrise Suppliers/Dealers and Zippie Customers on November 2013 by first class mail. Foreign notification was supplied to suppliers and regulatory affairs director in Canada. |
| Quantity | 316 units in US, 29 units international |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, Hong Kong, and China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123975 | QUICKIE & ZIPPIE SERIES Sunrise Medical, Aug 16, 2013 |