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
Electrode - Product Code GZL
원인
Mislabeled: may contain an electrode longer than labeled size.
조치
FHC notified customers via an Urgent: Medical Device Recall letter dated 10/20/08 advising users to remove the recalled electrodes from inventory and set the product aside for inspection by your FHC representative. Customers were asked to document their actions by completing the enclosed form and faxing it back to FHC at 207-666-8539.
Nationwide Distribution --- including states of CA, CO, FL, LA, NM, PA, TN, and PR.
제품 설명
FC4000 MicroTargeting Electrode Kit 5x || For use with Nexframe¿ and Nexdrive¿ || Distributed by Medtronic Inc., Minneapolis, MN || REF: FCH 4000 (5 Prefilled single use kits -5 packages and 2 electrodes each) || Intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain.