e-fix E20 power drive. The product is a wheelchair component/accessory.
FDA device recall Z-0804-05 · posted 2005-05-06 · Terminated
Recall details
- Recalling firm
- Frank Mobility Systems, Inc.
- Reason for recall
- may short circuit within the interface due to long term exposure of liquid
- Action taken
- The recalling firm issued a Corrective Action Notice to their customers on 9/1/04 via certified mail return receipt. The notice described the problem and the correction (interface was designed). The notice also instructed the dealers/distributors to notify their customers and have the units brought back to them for the exchange.
- Root cause
- Other
- Status
- Terminated
- Product code
- ITI
- Quantity affected
- 314 units
- Distribution
- The products were shipped to distributors nationwide. The product was also shipped to Mexico and Panama.
- Date initiated
- 2004-08-01
- Date posted
- 2005-05-06
- Date terminated
- 2006-08-23
- Location
- Oakdale, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POWER WHEELCHAIR CONVERSION KIT (K943789) | Alber Technologies, Inc. | 1994-11-08 |