Recall Z-2540-2020— FHC, Inc.
Class II · Terminated
Class II FDA medical device recall by FHC, Inc., initiated 2020-06-17, terminated 2020-11-02. It names one FDA 510(k) clearance: K183123. Product: 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: 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..
- Recalling firm
- FHC, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-17
- Terminated
- 2020-11-02
- Firm location
- Bowdoin, ME, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.