BEUDAMED
    FDA Recall Terminated

    FHC microTargeting Guideline 4000 ver 1.4 (GL4K) Software, Catalog # MT-GL4K. Intended to assist in functional neurological procedures.

    Recall: Z-1143-2010 · Initiated December 28, 2009

    Recall

    Recall Number
    Z-1143-2010
    Event Number
    54278
    Firm
    FHC, Inc.
    FEI Number
    3002250546
    Product Code
    GZL
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    December 28, 2009
    Posted
    March 16, 2010
    Terminated
    March 18, 2010
    Address
    1201 Main Street, Bowdoinham, ME, 04008

    Description

    FHC microTargeting Guideline 4000 ver 1.4 (GL4K) Software, Catalog # MT-GL4K. Intended to assist in functional neurological procedures.

    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.

    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.

    Distribution

    Worldwide Distribution -- USA, including states of GA, MA, NC, NJ, OH, RI, TN, TX, and WV and Bucharest, Romania.

    Quantity

    10