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U.S. Department of Health and Human Services

Class 2 Device Recall FHC Microtargeting Drive System

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  Class 2 Device Recall FHC Microtargeting Drive System see related information
Date Initiated by Firm October 08, 2008
Date Posted December 22, 2008
Recall Status1 Terminated 3 on May 02, 2012
Recall Number Z-0486-2009
Recall Event ID 50086
510(K)Number K011992  
Product Classification Stereotaxic Instrument - Product Code HAW
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.


Code Information Not coded.
Recalling Firm/
Manufacturer		 FHC, Inc.
1201 Main Street
Bowdoinham ME 04008
For Additional Information Contact SAME
207-666-8190
Manufacturer Reason
for Recall		 Measuring fixture is incorrectly graduated.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HAW and Original Applicant = FHC, INC.
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