Recall Z-2290-2016 ยท IOR Wheelchair, Mechanical
Sunrise Medical (US) LLC
Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of wheelchair's intended use is to provide mobility to persons limited to a sitting position.
| Date | Jul 25, 2016 (initiated Jul 1, 2016) |
| Status | Terminated |
| Reason | There is an observed failure of the backrest bracket which can fatigue over the life time of the product. When this occurs there is the possibility of the bracket fracturing causing the backrest to detach from the chair frame. |
| Root cause | Device Design |
| Action | The firm began calling dealers to alert them to the recall and obtain primary contacts information. Dealers were then sent their list of Quickie Q7 wheelchairs that records show being sold by them and dealers are asked to return a list of chairs they are able to locate for correction. The first dealer letter was sent via e-mail on July 7, 2016. |
| Quantity | 12,142 devices in US, 1,710 devices internationally. |
| Distribution | US and Mexico, Japan, Chile, Kuwait, Columbia, Hong Kong, China, Uruguay, South Africa, Costa Rica, South Korea, Singapore, New Zealand, El Salvador, Bahrain, Uruguay, Lebanon, United Arab Emirates, Brazil, Argentina, Netherlands Antilles, British Virgin Islands, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123975 | QUICKIE & ZIPPIE SERIES Sunrise Medical, Aug 16, 2013 |