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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 10, 2004
Create Date June 25, 2015
Recall Status1 Terminated 3 on October 06, 2004
Recall Number Z-0389-04
Recall Event ID 28581
Product Lodox Statscan digital radiographic system.
Code Information Serial numbers LDX002 and LDX004.
Recalling Firm/
Manufacturer		 Lodox Na Llc
23360 Clarkshire Dr
South Lyon MI 48178-8920
For Additional Information Contact William Greenway
248-446-8480
Manufacturer 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.
FDA Determined
Cause 2		 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.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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