Recall Z-1094-04 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Fischer Imaging Corporation
Fischer SenoScan True View Digital Mammography System.
| Date | Jul 20, 2004 (initiated May 21, 2004) |
| Status | Terminated |
| Reason | Existing software may allow Image data to be truncated in the margin of the breast on processed patient images. |
| Root cause | Other |
| Action | Customers were notified by phone and certified letter on 05/21/2004. |
| Quantity | 12 units |
| Distribution | FL, NC, NY, OK, WI. Foreign distribution to France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.