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Class 3 Device Recall Drystar DT2 Mammo |
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Date Initiated by Firm |
April 22, 2010 |
Date Posted |
June 11, 2010 |
Recall Status1 |
Terminated 3 on February 01, 2011 |
Recall Number |
Z-1799-2010 |
Recall Event ID |
55658 |
Product Classification |
System, image processing, radiological - Product Code LLZ
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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 SC 29601-2632
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For Additional Information Contact |
Jeffery A. Jedlicka 864-421-1815
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Manufacturer Reason for Recall |
The RF tags on the white protection sheets of the media stacks were incorrect.
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FDA Determined Cause 2 |
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
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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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