Recall Z-0149-04 ยท IZH System, X-Ray, Mammographic
Lorad, A Division of Hologic
Lorad MIV Platinum Mammograpgy System
| Date | Aug 11, 2004 (initiated Jan 14, 2004) |
| Status | Terminated |
| Reason | System failed to meet the mA's accuracy specfications at low mA's values |
| Root cause | Other |
| Action | Lorad notified customers/dealers by letter dated January 14, 2004. Sites were advised of the corrected Accuracy labeling. |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011987 | MODIFIED M-IV MAMMOGRAPHY SYSTEM Lorad, A Hologic Co., Jul 11, 2001 |