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.
This recall has been terminated (originally issued December 22, 2008).
- Company
- Fhc, Inc.
- Recall Initiated
- October 8, 2008
- Posted
- December 22, 2008
- Terminated
- May 2, 2012
- Recall Number
- Z-0486-2009
- Quantity
- 5 units
- Firm Location
- Bowdoinham, ME
- Official Source
- View on FDA website ↗
Reason for Recall
Measuring fixture is incorrectly graduated.
Distribution
Nationwide Distribution including states of CO, FL, NC and NM.
Lot / Code Info
Not coded.
Root Cause
Process control
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.
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