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
Reported: July 15, 2020 Initiated: June 17, 2020 #Z-2540-2020
Product Description
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
Reason for Recall
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.
Details
- Recalling Firm
- FHC, Inc.
- Units Affected
- 6 units
- Distribution
- US Nationwide distribution including in the states of CA, NC, TN, TX, WA.
- Location
- Bowdoin, ME
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by FHC, Inc.. Units affected: 6 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 15, 2020. Severity: Moderate. Recall number: Z-2540-2020.
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