Solid state x-ray imager — Class II medical device recall Z-1391-2018
Terminated recall by NeuroLogica Corporation, reported 2018-04-25. While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential
| Recall number | Z-1391-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NeuroLogica Corporation, Danvers, MA, United States |
| Recall initiated | 2018-01-12 |
| Classified | 2018-04-17 |
| Reported by FDA | 2018-04-25 |
| Terminated | 2018-08-14 |
| Quantity | 16 units |
| Serial numbers | 00001 |
| Model numbers | GMR40 |
Product
Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical
Reason for recall
While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit.
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-1391-2018. 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.