FDAFDA · Food and drugs·Recall number Z-2540-2020
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
Published July 15, 2020 · Recall initiated: June 17, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- FHC, Inc.
- Distributor
- US Nationwide distribution including in the states of CA, NC, TN, TX, WA.
- Lot
- Serial Numbers: 45695, 48871, 48873, 48874, 46195, 46198
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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