Jul

2010

Cl ll FHC micro Targeting Guideline 4000 v 1.4

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.

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl ll FHC micro Targeting Guideline 4000 v 1.4

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