FDA Recall
Terminated
Lodox Statscan digital radiographic system.
Recall: Z-0389-04
·
Initiated May 10, 2004
Recall
- Recall Number
- Z-0389-04
- Event Number
- 28581
- Firm
- Lodox Na Llc
- FEI Number
- 3004035693
- Status
- Terminated
- Root Cause
- Other
- Initiated
- May 10, 2004
- Terminated
- October 6, 2004
- Address
- 23360 Clarkshire Dr, South Lyon, MI, 48178-8920
Description
Lodox Statscan digital radiographic system.
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.
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.
Distribution
Illinois and Maryland.
Quantity
2