FDA Medical Device Recalls (openFDA)
FHC, Inc.: FHC microTargeting Guideline 4000 ver 1.4 (GL4K) Software, Catalog # MT-GL4K. Intended to assist in functional neurological procedures.
- Recall number
- Z-1143-2010
- Recalling firm
- FHC, Inc.
- Product
- FHC microTargeting Guideline 4000 ver 1.4 (GL4K) Software, Catalog # MT-GL4K. Intended to assist in functional neurological procedures.
- Status
- Terminated
- Initiated
- 2009-12-28
- Posted
- 2010-03-16
- Terminated
- 2010-03-18
- 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.
- Root cause
- Software change control
- Action
- FHC notified customers by telephone and by an Urgent: Medical Device Correction email, dated December 2009, beginning December 28th. Customers have been instructed to keep the instruction with the GL4K until FHC can provide a revision to the software; and, to use only "distance from zero" or "distance traveled" modes (not "distance from target" mode) during procedures using the raster tab. Customers are to notify their FHC representative to confirm receipt of the notification. A software patch has been verified and validated and will be installed on all affected units. The new version of the corrected software is Guideline 4000 version 1.41. Questions should be directed to Jason Moyer, product manager or Keri Seitz, recall coordinator at 207-666-8190.
- Quantity
- 10
- Distribution
- Worldwide Distribution -- USA, including states of GA, MA, NC, NJ, OH, RI, TN, TX, and WV and Bucharest, Romania.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K071364"]
- PMA numbers
- not on file
- Product code
- GZL
- Firm FEI
- 3002250546
- Firm city
- Bowdoinham
- Firm state
- ME
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28