Sunrise Medical Quickie Groove Power Wheelchair with Transit option The product is a powered wheelchair for human use.
FDA device recall Z-2339-2008 · posted 2008-09-23 · Terminated
Recall details
- Recalling firm
- Sunrise Medical Inc
- Reason for recall
- Rear bolts holding the frame in place may shear and the front bolts may potentially come off the posts, resulting in partial or full seat detachment in a sudden stop or crash.
- Action taken
- Initial phone contacts began on November 13, 2006. Letters were also mailed. The letter informed the customer of the problem and provided interim steps to take, until an transit upgrade kit is installed. Response cards will be tracked to measure response rate and assure receipt of notice. Contact Sunrise Medical at 1-800-456-8168 for assistance.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- ITI
- Quantity affected
- 36 units
- Distribution
- Worldwide: US, Canada, New Zealand and Australia.
- Date initiated
- 2006-11-13
- Date posted
- 2008-09-23
- Date terminated
- 2009-12-22
- 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 RHYTHM & GROOVE SERIES POWER WHEELCHAIRS W/QUICKIE DELPHI CONTROLS (K060531) | Sunrise Medical | 2006-03-17 |