Recall Z-2540-2020 ยท GZL Electrode, Depth
FHC, Inc.
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
| Date | Jun 17, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Component change control |
| Action | 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. |
| Quantity | 6 units |
| Distribution | US Nationwide distribution including in the states of CA, NC, TN, TX, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183123 | microTargeting Guideline 4000 5.0 System FHC, Inc., Dec 20, 2018 |