FDA Device

DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. Agfa Corporation. Greenville, SC 29601. Intended to display mammographic images.

Hazard

The RF tags on the white protection sheets of the media stacks were incorrect.

What You Should Do

Remedy

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.

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Products

DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. Agfa Corporation. Greenville, SC 29601. Intended to display mammographic images.
Brand
AGFA Corp.
UPC
Lot Number: 36810031 (115 stacks) and Lot Number: 36750062 (65 stacks).

Units Affected

180 boxes

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