Recall Z-1143-2010
FHC, Inc. · initiated December 28, 2009
Product
FHC microTargeting Guideline 4000 ver 1.4 (GL4K) Software, Catalog # MT-GL4K. Intended to assist in functional neurological procedures.
Codes / lots: 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
Reason for recall
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-determined cause: Software change control
Action taken
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.
Details
- Recall number
- Z-1143-2010
- Initiated
- December 28, 2009
- Posted by FDA
- March 16, 2010
- Terminated
- March 18, 2010
- Product code
- GZL – Electrode, Depth
- Quantity
- 10
- Distribution
- Worldwide Distribution -- USA, including states of GA, MA, NC, NJ, OH, RI, TN, TX, and WV and Bucharest, Romania.
- Recalling firm
- FHC, Inc., Bowdoinham, ME