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Device Recall FHC
Model / Serial
All codes
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Natiowide
Product Description
FHC 66-ZD-MD microTargeting Drive System: System for Stereotactic Positioning || Used with the Power Assist (66-DA-ME) or Display Assembly (66-DA-EN)
Manufacturer
FHC, Inc.
1 Event
Recall of Device Recall FHC
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Manufacturer
FHC, Inc.
Manufacturer Address
FHC, Inc., 9 Main St, Bowdoinham ME 04008-4418
Source
USFDA
One device with a similar name
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Device Recall FHC microTargeting Guideline 4000
Model / Serial
Software ver 1.4, Serial Numbers: 19454, 14423, 17349, 19215, 15573, 19424, 17583, 17589, 17588, and 17581. This version of software was released in August 2009
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- USA, including states of GA, MA, NC, NJ, OH, RI, TN, TX, and WV and Bucharest, Romania.
Product Description
FHC microTargeting Guideline 4000 ver 1.4 (GL4K) Software, || Catalog # MT-GL4K. || Intended to assist in functional neurological procedures.
Manufacturer
FHC, Inc.
Language
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