Z-0389-04

Lodox Statscan digital radiographic system

Name: Z-0389-04 Lodox Statscan digital radiographic system
Creator: Lodox Na Llc
Published: 2004-05-10
License: https://open.fda.gov/license/

Lodox Na LLC / initiated 2004-05-10 / Terminated / root cause: labeling and UDI

FDA source

Lodox Na Llc began a recall of Lodox Statscan digital radiographic system on 2004-05-10. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0389-04
Status: Terminated
Initiated: 2004-05-10
Posted: 2015-06-25
Terminated: 2004-10-06
Recalling firm: Lodox Na LLC
Product: Lodox Statscan digital radiographic system.
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 2
Distribution: Illinois and Maryland.
Product codes and lots: Serial numbers LDX002 and LDX004.

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)