FDA Medical Device Recalls (openFDA)
FHC, Inc.: FHC microTargeting Platform DBS Measuring Fixture, a component of the micro-targeting Drive System (Catalog Number 66-FA-SF). The device is a stereotactic instrument used for the placement of recording and stimulating electrodes in the brain.
- Recall number
- Z-0486-2009
- Recalling firm
- FHC, Inc.
- Product
- FHC microTargeting Platform DBS Measuring Fixture, a component of the micro-targeting Drive System (Catalog Number 66-FA-SF). The device is a stereotactic instrument used for the placement of recording and stimulating electrodes in the brain.
- Status
- Terminated
- Initiated
- 2008-10-08
- Posted
- 2008-12-22
- Terminated
- 2012-05-02
- Reason
- Measuring fixture is incorrectly graduated.
- Root cause
- Process control
- Action
- FHC provided letter notification to FHC Field Representatives on 10/08/08 to hand deliver to customers. FHC Field Representatives will remove incorrectly marked product and provide replacement product. Direct questions to an FHC representative or FHC Quality and Regulatory Affairs at 207-666-5651, ext. 2210.
- Quantity
- 5 units
- Distribution
- Nationwide Distribution including states of CO, FL, NC and NM.
- Lot, serial or model codes
- Not coded.
- 510(k) numbers
- ["K011992"]
- PMA numbers
- not on file
- Product code
- HAW
- 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