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.
FDA Recall Z-0486-2009 · Posted 2008-12-22
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Recalling FirmFHC, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2008-10-08
Date Terminated2012-05-02
Product Quantity5 units
Reason for Recall
Measuring fixture is incorrectly graduated.
Firm 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.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution including states of CO, FL, NC and NM.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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