FHC recalls GL5 Main Processing Units with serial numbers 45695, 48871, 48873, 48874, 46195, 46198 due to potential ESD interference. Affected units may malfunction during high-voltage events.
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.
FHC is recalling its GL5 Main Processing Units because an electrical connection issue could cause interference if a high-voltage event occurs. This might lead to incorrect readings or device malfunction during electrophysiological testing.
The device has an electrical sub-circuit that wasn't properly connected. This could cause interference if a high-voltage event (ESD greater than 6kV) happens, potentially leading to incorrect readings or device malfunction during medical procedures.
Users of FHC Guideline 4000 5.0 GL5 Main Processing Units for medical electrophysiological testing are affected. Healthcare professionals using these devices for patient monitoring or electrode placement are most at risk.
Check for serial numbers 45695, 48871, 48873, 48874, 46195, or 46198 on the device. The product is part of the FHC Guideline 4000 5.0 series used for medical electrophysiological testing.
Verify your device's serial number against the list: 45695, 48871, 48873, 48874, 46195, 46198.
An electrical sub-circuit wasn't properly connected, which could cause interference if a high-voltage event (ESD greater than 6kV) occurs.
Check for serial numbers 45695, 48871, 48873, 48874, 46195, or 46198 on the device.
No, the recall does not require stopping use. The hazard is low risk and only affects specific serial numbers.
We’ve drafted a message you can send FHC to request your refund or repair — edit it as you like.
Subject: Recall Z-2540-2020 — FHC FHC Hello, I own a FHC that is covered by recall Z-2540-2020 from FHC. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
