Class 3 Device Recall Drystar DT2 Mammo

• Date Initiated by Firm: April 22, 2010
• Date Posted: June 11, 2010
• Recall Status: 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 SC 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: 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 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.