Z-2540-2020 Class II Terminated
FDA device recall Z-2540-2020 was initiated by FHC, Inc. on June 17, 2020 and is designated Class II. 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 (grea… The recall status is terminated (terminated November 2, 2020). Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2020
- Initiation Date
- June 17, 2020
- Termination Date
- November 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
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.
Distribution Pattern
US Nationwide distribution including in the states of CA, NC, TN, TX, WA.
Code Information
Serial Numbers: 45695, 48871, 48873, 48874, 46195, 46198