Devices

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.
1 Event
- Recall of Device Recall FHC microTargeting Guideline 4000

Manufacturer

FHC, Inc.

Manufacturer Address
FHC, Inc., 1201 Main Street, Bowdoinham ME 04008
Manufacturer Parent Company (2017)
Fhc Inc.
Source
USFDA

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