Recall Z-0486-2009 ยท HAW Neurological Stereotaxic Instrument
FHC, Inc.
FHC microTargeting Platform DBS Measuring Fixture, a component of the micro-targeting Drive System (Catalog Number 66-FA-SF). The device is a stereotactic instrument used for the placement of recording and stimulating electrodes in the brain.
| Date | Dec 22, 2008 (initiated Oct 8, 2008) |
| Status | Terminated |
| Reason | Measuring fixture is incorrectly graduated. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 5 units |
| Distribution | Nationwide Distribution including states of CO, FL, NC and NM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011992 | FHC MICROTARGETING DRIVE SYSTEM FHC, Inc., Aug 14, 2001 |