Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile… — Class II medical device recall Z-1414-2023
Ongoing recall by NeuroLogica Corporation, reported 2023-04-26, distributed nationwide. Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm
| Recall number | Z-1414-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | NeuroLogica Corporation, Danvers, MA, United States |
| Recall initiated | 2023-03-08 |
| Classified | 2023-04-19 |
| Reported by FDA | 2023-04-26 |
| Distributed | Nationwide (US) |
| Quantity | 935 units |
| UPC / GTIN / UDI-DI | 08806088582412 |
Product
Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
Reason for recall
Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a fall of the arm
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-1414-2023. 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.