CLASS II Device recall · Reported 14 Mar 2018 · FDA Enforcement Report
The GC80 Digital X-ray Imaging System recalled by NeuroLogica
NeuroLogica is recalling The GC80 Digital X-ray Imaging System, distributed nationwide in the US. The recall was initiated on 22 Jun 2017 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-0726-2018
- FDA event ID
- 78679
- Recalling firm
- NeuroLogica, Danvers, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Jun 2017
- FDA classified
- 2 Mar 2018
- Reported
- 14 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 22 Jun 2017 | Recall initiated by company | |
| 2 Mar 2018 | Classified by FDA | +253 days |
| 14 Mar 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An image was obtained with over exposure during a Thorax examination using the AEC function.
Product as listed by the FDA
The GC80 Digital X-ray Imaging System
Where it was distributed
Nationwide US
Questions about this recall
Why was it recalled?
An image was obtained with over exposure during a Thorax examination using the AEC function.
Which lots are affected?
Accession Number 1310459
Where was it sold?
Nationwide US
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 26 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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| Device | CLASS II | OmniTom/OmniTom Elite- X-ray computed tomography recalled by NeuroLogica | NeuroLogica | Other | Nationwide |
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Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |