Quickie brand Freestyle M11 & F11, C. G. Tilt, Powered Wheelchair; Product is manufactured and distributed by Sunrise Me
FDA device recall Z-0518-06 · posted 2006-02-14 · Terminated
Recall details
- Recalling firm
- Sunrise Medical Inc
- Reason for recall
- While operating the powered wheelchair beyond a specified angle of recline, the wheelchair can travel at an unsafe speed when in this position.
- Action taken
- On November 9, 2005, the firm contacted its consignees via telephone, which was followed up by a mailing, to alert them of the situation. The firm is making arrangements to conduct the service correction at users'' residence. All appointmens are scheduled to be completed by December 15, 2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- ITI
- Quantity affected
- 5 units
- Distribution
- All 5 units were distributed to direct consignees, in CA, MA, NC, and OH.
- Date initiated
- 2005-11-15
- Date posted
- 2006-02-14
- Date terminated
- 2006-12-28
- 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 FREESTYLE POWER WHEELCHAIR, MODEL G-424 (K031289) | Sunrise Medical, Inc. | 2003-05-09 |