Recall archive
3 recalls · page 1 of 1
Reported Nov 20, 2024
microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode…
High riskUsing this product could cause serious injury, illness or death — stop using it now.FHC, Inc.
Matched: Brand — A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is…
FDA (openFDA device enforcement)
Reported Jul 15, 2020
FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.FHC, Inc.
Matched: Brand · Product · Product details — An electrical sub-circuit was not properly connected. Its purpose is to eliminate the possibility of interference with proper performance of the…
FDA (openFDA device enforcement)
Reported Jul 11, 2018
microTargeting" Drive System, Product Number MT-DS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.FHC, Inc.
Matched: Brand · Reason for recall — The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can…
14 more products in this recall
FDA (openFDA device enforcement)
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