Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of wheelchair's intended use is to provide mo
FDA device recall Z-2290-2016 · posted 2016-07-25 · Terminated
Recall details
- Recalling firm
- Sunrise Medical (US) LLC
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IOR
- Quantity affected
- 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, B
- Date initiated
- 2016-07-01
- Date posted
- 2016-07-25
- Date terminated
- 2017-09-11
- Location
- Fresno, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| QUICKIE & ZIPPIE SERIES (K123975) | Sunrise Medical | 2013-08-16 |