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FHC microTargeting Guideline 4000 ver 1.4 (GL4K) Software recallZ-1143-2010 · FHC, Inc. · initiated Dec 28, 2009

Terminated All recalls posted in March 2010

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from FHC, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software change control

What the company is doing

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.

Recall details

Recall number
Z-1143-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 28, 2009
Posted by the FDA
Mar 16, 2010
Recalling firm
FHC, Inc.
Quantity
10
Product code
GZL
FDA submissions
K071364
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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

1 device cleared under K071364 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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