Lorad M-IV Mammography System
FDA device recall Z-0148-04 · posted 2004-08-11 · Terminated
Recall details
- Recalling firm
- Lorad, A Division of Hologic
- Reason for recall
- System failed to meet the mA's accuracy specfications at low mA's values
- Action taken
- Lorad notified customers/dealers by letter dated January 14, 2004. Sites were advised of the corrected Accuracy labeling.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZH
- Distribution
- Nationwide
- Date initiated
- 2004-01-14
- Date posted
- 2004-08-11
- Date terminated
- 2004-09-15
- Location
- Danbury, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFIED M-IV MAMMOGRAPHY SYSTEM (K011987) | Lorad, A Hologic Co. | 2001-07-11 |