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Terminated

Lodox Statscan digital radiographic system.

FDA Recall Z-0389-04 · Posted None

Recalling FirmLodox Na Llc
Recall StatusTerminated
Date Initiated2004-05-10
Date Terminated2004-10-06
Product Quantity2

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Illinois and Maryland.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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