DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. Agfa Corporation. Greenville, SC 29601. Intended to display mammographic images.
- Company
- Agfa Corp.
- Recall Initiated
- April 22, 2010
- Posted
- June 11, 2010
- Terminated
- February 1, 2011
- Recall Number
- Z-1799-2010
- Quantity
- 180 boxes
- Firm Location
- Greenville, SC
Reason for Recall
The RF tags on the white protection sheets of the media stacks were incorrect.
Distribution
Worldwide Distribution -- United States (AL, CT, FL, KS, MA, MI, NJ, NM, NY, PA and WV), British Columbia and Guatemala.
Lot / Code Info
Lot Number: 36810031 (115 stacks) and Lot Number: 36750062 (65 stacks).
Root Cause
Nonconforming Material/Component
Action Taken
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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