FDAJune 17, 2020device
FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments. Catalogue Number: C0215 UDI: 00873263006740
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
An electrical sub-circuit was not properly connected. Its purpose is to eliminate the possibility of interference with proper performance of the Guideline 5 Main Processing Unit, if an ESD event (greater than 6kV) were to occur.
What to do
FDA enforcement status: Terminated
Brands named
fhc
UPCs
00873263006740
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAmicroTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.2024-10-04
- FDAmicroTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME2018-05-10
- FDAmicroTargeting" Drive System, Product Number 66-ZD-MD-012018-05-10
- FDAmicroTargeting" STar" Drive System (Manual), Product Number ST-DS-MA2018-05-10
- FDAmicroTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME2018-05-10
- FDAmicroTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB2018-05-10
- FDAmicroTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB2018-05-10
- FDAmicroTargeting" Drive System, Product Number MT-DS2018-05-10
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