Z-0486-2009

FHC microTargeting Platform DBS Measuring Fixture, a component of the micro-targeting Drive System (Catalog...

Name: Z-0486-2009 FHC microTargeting Platform DBS Measuring Fixture, a component of the micro-targeting Drive System (Catalog...
Creator: FHC, Inc.
Published: 2008-10-08
License: https://open.fda.gov/license/

FHC, Inc. / initiated 2008-10-08 / Terminated / root cause: manufacturing process

FDA source

FHC, Inc. began a recall of FHC microTargeting Platform DBS Measuring Fixture, a component of the micro-targeting Drive System (Catalog Number 66-FA-SF). The device is a stereotactic... on 2008-10-08. The reason FDA records is "Measuring fixture is incorrectly graduated". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0486-2009
Status: Terminated
Initiated: 2008-10-08
Posted: 2008-12-22
Terminated: 2012-05-02
Recalling firm: FHC, Inc.
Product: 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.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Measuring fixture is incorrectly graduated.
Root cause tag: manufacturing process
FDA 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 in commerce: 5 units
Distribution: Nationwide Distribution including states of CO, FL, NC and NM.
Product codes and lots: Not coded.

Product code HAW

K011992Class IIFhc Microtargeting Drive SystemFHC, Inc. / cleared 2001-08-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)