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U.S. Department of Health and Human Services

Class 3 Device Recall Drystar DT2 Mammo

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 Class 3 Recall
Drystar DT2 Mammo
see related information
Date Posted June 11, 2010
Recall Status1 Terminated on February 01, 2011
Recall Number Z-1799-2010
Recall Event ID 55658
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. Agfa Corporation. Greenville, SC 29601. Intended to display mammographic images.
Code Information Lot Number: 36810031 (115 stacks) and Lot Number: 36750062 (65 stacks).
Recalling Firm/
Manufacturer
AGFA Corp.
10 S Academy St
Greenville, South Carolina 29601-2632
For Additional Information Contact Jeffery A. Jedlicka
864-421-1815
Manufacturer Reason
for Recall
The RF tags on the white protection sheets of the media stacks were incorrect.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action AGFA Healthcare issued an "Urgent Safety Notice" dated April 22, 2010 requesting a check of warehouse inventory and a request for a sub-recall, if necessary. All affected product should be returned to the firm for replacement. For further information, contact AGFA Healthcare at 1-877-777-2432.
Quantity in Commerce 180 boxes
Distribution Worldwide Distribution -- United States (AL, CT, FL, KS, MA, MI, NJ, NM, NY, PA and WV), British Columbia and Guatemala.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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