Recall Z-1799-2010 ยท LLZ System, Image Processing, Radiological
AGFA Corp.
DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. Agfa Corporation. Greenville, SC 29601. Intended to display mammographic images.
| Date | Jun 11, 2010 (initiated Apr 22, 2010) |
| Status | Terminated |
| Reason | The RF tags on the white protection sheets of the media stacks were incorrect. |
| Root 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 | 180 boxes |
| Distribution | Worldwide Distribution -- United States (AL, CT, FL, KS, MA, MI, NJ, NM, NY, PA and WV), British Columbia and Guatemala. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.