Recall Z-0916-2012 ยท IWZ Film, Radiographic
AGFA Corp.
Drystar Mammo. Display of Mammographic images.
| Date | Mar 2, 2010 |
| Status | Terminated |
| Reason | Labeling problem |
| Root cause | Error in labeling |
| Action | The firm, AGFA Corporation spoke to the customer directly via telephone concerning the mislabeled affected products. The firm also contacted the customer via e-mail on April 13, 2011 explaining the outcome of the customer complaint. Replacement product was sent to the customer. |
| Quantity | 2 boxes |
| Distribution | Product distributed in Florida. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.