FHC microTargeting Platform DBS Measuring Fixture, a component of the micro-targeting Drive System (Catalog Number 66-FA
FDA device recall Z-0486-2009 · posted 2008-12-22 · Terminated
Recall details
- Recalling firm
- FHC, Inc.
- Reason for recall
- Measuring fixture is incorrectly graduated.
- Action taken
- FHC provided letter notification to FHC Field Representatives on 10/08/08 to hand deliver to customers. FHC Field Representatives will remove incorrectly marked product and provide replacement product. Direct questions to an FHC representative or FHC Quality and Regulatory Affairs at 207-666-5651, ext. 2210.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 5 units
- Distribution
- Nationwide Distribution including states of CO, FL, NC and NM.
- Date initiated
- 2008-10-08
- Date posted
- 2008-12-22
- Date terminated
- 2012-05-02
- Location
- Bowdoinham, ME
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FHC MICROTARGETING DRIVE SYSTEM (K011992) | FHC, Inc. | 2001-08-14 |