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Terminated

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

FDA Recall Z-1799-2010 · Posted 2010-06-11

Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2010-04-22
Date Terminated2011-02-01
Product Quantity180 boxes

Reason for Recall

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

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution -- United States (AL, CT, FL, KS, MA, MI, NJ, NM, NY, PA and WV), British Columbia and Guatemala.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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