FDA Medical Device Recalls (openFDA)
Frank Mobility Systems, Inc.: e-fix E19 power drive. The product is a wheelchair component/accessory.
- Recall number
- Z-0803-05
- Recalling firm
- Frank Mobility Systems, Inc.
- Product
- e-fix E19 power drive. The product is a wheelchair component/accessory.
- Status
- Terminated
- Initiated
- 2004-08-01
- Posted
- 2005-05-06
- Terminated
- 2006-08-23
- Reason
- may short circuit within the interface due to long term exposure of liquid
- Root cause
- Other
- Action
- 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.
- Quantity
- 314 units
- Distribution
- The products were shipped to distributors nationwide. The product was also shipped to Mexico and Panama.
- Lot, serial or model codes
- Model number E19
- 510(k) numbers
- ["K943789"]
- PMA numbers
- not on file
- Product code
- ITI
- Firm FEI
- 1000522778
- Firm city
- Oakdale
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28