FHC microTargeting Platform DBS Measuring Fixture recallZ-0486-2009 · FHC, Inc. · initiated Oct 8, 2008
Terminated All recalls posted in December 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from FHC, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Measuring fixture is incorrectly graduated.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0486-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 8, 2008
- Posted by the FDA
- Dec 22, 2008
- Recalling firm
- FHC, Inc.
- Quantity
- 5 units
- Product code
- HAW
- FDA submissions
- K011992
- Distribution
- Nationwide Distribution including states of CO, FL, NC and NM.
Product description
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.
Code information (models, lots, serial numbers)
Not coded.
Other devices under the same FDA submission
2 devices cleared under K011992 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- microTargeting™ Drive DBS Adapter 66-CN-DB-00453Fhc, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- microTargeting™ Sterile Drape Sleeve 66-DA-SD-00436Fhc, Inc. · Neurological stereotaxic Instrument1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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