FDA Medical Device Recalls (openFDA)
Lodox Na Llc: Lodox Statscan digital radiographic system.
- Recall number
- Z-0389-04
- Recalling firm
- Lodox Na Llc
- Product
- Lodox Statscan digital radiographic system.
- Status
- Terminated
- Initiated
- 2004-05-10
- Posted
- not on file
- Terminated
- 2004-10-06
- Reason
- The labels do not have proper identification and certification and the firm failed to provide adequate test and quality control procedures to establish certification by the manufacturer.
- Root cause
- Other
- Action
- The device in Illinois was re-exported. The device in Maryland was tested on 5/10/04 by a trained Lodox representative and proper labeling was reportedly attached.
- Quantity
- 2
- Distribution
- Illinois and Maryland.
- Lot, serial or model codes
- Serial numbers LDX002 and LDX004.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 3004035693
- Firm city
- South Lyon
- Firm state
- MI
- 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