The GC80 Digital X-ray Imaging System — Class II medical device recall Z-0726-2018
Terminated recall by NeuroLogica Corporation, reported 2018-03-14, distributed nationwide. An image was obtained with over exposure during a Thorax examination using the AEC function.
| Recall number | Z-0726-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NeuroLogica Corporation, Danvers, MA, United States |
| Recall initiated | 2017-06-22 |
| Classified | 2018-03-02 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2018-10-05 |
| Distributed | Nationwide (US) |
| Quantity | 45 units |
Product
The GC80 Digital X-ray Imaging System
Reason for recall
An image was obtained with over exposure during a Thorax examination using the AEC function.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0726-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.