3G Storm Series Power Wheelchair with Power Tilt Option.
FDA device recall Z-0303-06 · posted 2005-12-23 · Terminated
Recall details
- Recalling firm
- Invacare Corporation
- Reason for recall
- When the powered seating system is tilted completely in the rearward position, a potential pinch point is created between the seat and the seat frame.
- Action taken
- The recalling firm sent letters to all consignees.
- Root cause
- Other
- Status
- Terminated
- Product code
- ITI
- Quantity affected
- 16 devices
- Distribution
- The product was sent to distributors located in AL, GA, CA, IL, KS, MN, NC, PA, TX, and VA.
- Date initiated
- 2005-10-11
- Date posted
- 2005-12-23
- Date terminated
- 2012-04-12
- Location
- Elyria, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODEL CGS TILT SEATING SYSTEM FOR POWER WHEELCHAIRS (K001777) | Invacare Corp. | 2000-07-24 |
| STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE CONTROL (K993413) | Invacare Corp. | 1999-12-15 |