CLASS II Device recall · Reported 15 Jul 2020 · FDA Enforcement Report
Guideline 4000 0 GL5 Main Processing Unit recalled by FHC
FHC is recalling FHC Guideline 4000 0 GL5 Main Processing Unit, distributed nationwide in the US. The recall was initiated on 17 Jun 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2540-2020
- FDA event ID
- 85897
- Recalling firm
- FHC, Bowdoin, ME
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jun 2020
- FDA classified
- 8 Jul 2020
- Reported
- 15 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 17 Jun 2020 | Recall initiated by company | |
| 8 Jul 2020 | Classified by FDA | +21 days |
| 15 Jul 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution including in the states of CA, NC, TN, TX, WA.
Questions about this recall
Is Guideline 4000 0 GL5 Main Processing Unit recalled?
Yes. FHC recalled Guideline 4000 0 GL5 Main Processing Unit on 17 Jun 2020. The recall is Class II and its status is Terminated. Recall number Z-2540-2020.
Why was it recalled?
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.
Which lots are affected?
Serial Numbers: 45695, 48871, 48873, 48874, 46195, 46198
Where was it sold?
US Nationwide distribution including in the states of CA, NC, TN, TX, WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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