LATERAL BIOPSY PLATE - For use with the Liberty 9000, 8-Channel Breast Coil. The Lateral Biopsy plate is sent to custome
FDA device recall Z-0505-2007 · posted 2007-02-15 · Terminated
Recall details
- Recalling firm
- USA Instruments Incorporated
- Reason for recall
- The packaging used for the Breast Biopsy Plate may exhibit small holes or tears.
- Action taken
- Customers were notifed by certified letter, dated 11/28/06.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 250 units
- Distribution
- Nationwide.
- Date initiated
- 2006-11-21
- Date posted
- 2007-02-15
- Date terminated
- 2012-04-13
- Location
- Aurora, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 3T HD BREAST ARRAY (K052585) | Usa Instruments, Inc. | 2005-10-04 |
| LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE (K041695) | Usa Instruments, Inc. | 2004-07-23 |