Company:FHC, Inc,.
Date of Enforcement Report 6/30//2010
Class ll:
PRODUCT
FHC micro Targeting Guideline 4000 version 1.4 (GL4K) Software, Catalog # MT-GL4K. Int. This version of software was released in August 2009. Recall # Z-1143-2010
REASON
The raster tab for the GL4K version 1.4 software may assign incorrect depths for waveform recordings and if used to identify the implantation target for the DBS lead, the implant may be placed in the wrong location.
RECALLING FIRM/MANUFACTURER
FHC, Inc., Bowdoinham, ME, by telephone and by email, dated December 2009, beginning December 28th. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
GA, MA, NC, NJ, OH, RI, TN, TX, and WV and Bucharest, Romania.
