Recall Z-2540-2020
FHC, Inc. · initiated June 17, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Serial Numbers: 45695, 48871, 48873, 48874, 46195, 46198
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.
FDA-determined cause: Component change control
Action taken
FHC issued Urgent Medical Device Recall letter dated 6/17/20 via USPS certified return receipt,stating reason for recall, health risk and action to take: FHC, Inc. field representatives will be contacting you to return the effected product and issue a replacement. In the interim, we advise you to stop use of this product. Should you have any further questions regarding this matter you may contact me, by email at kmoeykens@fh-co.com or by telephone at 207-666-5425.
Details
- Recall number
- Z-2540-2020
- Initiated
- June 17, 2020
- Terminated
- November 2, 2020
- Product code
- GZL – Electrode, Depth
- Quantity
- 6 units
- Distribution
- US Nationwide distribution including in the states of CA, NC, TN, TX, WA.
- Recalling firm
- FHC, Inc., Bowdoin, ME