U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Stereotaxic Instrument - Product Code HAW
원인
Measuring fixture is incorrectly graduated.
조치
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.
Nationwide Distribution including states of CO, FL, NC and NM.
제품 설명
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.