Recall Z-1143-2010 ยท GZL Electrode, Depth
FHC, Inc.
FHC microTargeting Guideline 4000 ver 1.4 (GL4K) Software, Catalog # MT-GL4K. Intended to assist in functional neurological procedures.
| Date | Mar 16, 2010 (initiated Dec 28, 2009) |
| Status | Terminated |
| 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 t |
| Quantity | 10 |
| Distribution | Worldwide Distribution -- USA, including states of GA, MA, NC, NJ, OH, RI, TN, TX, and WV and Bucharest, Romania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071364 | MICROTARGETING GUIDELINE 4000 FHC, Inc., Jul 25, 2007 |