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U.S. Department of Health and Human Services

Class 3 Device Recall Agfa Digital Radiography XRay System DXD 100

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  Class 3 Device Recall Agfa Digital Radiography XRay System DXD 100 see related information
Date Initiated by Firm May 13, 2014
Date Posted August 10, 2014
Recall Status1 Terminated 3 on August 13, 2014
Recall Number Z-2176-2014
Recall Event ID 68798
510(K)Number K103597  
Product Classification System, x-ray, mobile - Product Code IZL
Product Agfa Digital Radiography X-Ray System DX-D 100

Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.
Code Information Serial Number A5410000042
Recalling Firm/
Manufacturer
AGFA Healthcare Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Debbie Huff
864-421-1754
Manufacturer Reason
for Recall
Unit was mislabeled with a factory label showing 32 KW output power.
FDA Determined
Cause 2
Labeling mix-ups
Action Only one customer was affected no customer letter was issued field correction was conducted..
Quantity in Commerce 1
Distribution US in the state of WV
Total Product Life Cycle TPLC Device Report

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.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = AGFA HEALTHCARE N.V.
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