Samsung Digital Diagnostic Mobile X-ray System — Class II medical device recall Z-1056-2024
Ongoing recall by NeuroLogica Corporation, reported 2024-02-21, distributed nationwide. Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of
| Recall number | Z-1056-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | NeuroLogica Corporation, Danvers, MA, United States |
| Recall initiated | 2023-12-28 |
| Classified | 2024-02-09 |
| Reported by FDA | 2024-02-21 |
| Distributed | Nationwide (US) |
| Quantity | 261 devices |
| UPC / GTIN / UDI-DI | 08806088582412 |
| Serial numbers | 513YM3IJA00001X, 513YM3IK100001A, 513YM3IK100002D, 513YM3IK100003N, 513YM3IK400001W, 513YM3IK400002A, 513YM3IK500001K, 513YM3IK500002R, 513YM3IK500003Z, 513YM3IK500004H, 513YM3IK500005Y, 5143M3DHB00001M, 5143M3GK500001H, 5143M3GK500002Y, 5143M3GK500003J, 5143M3GK500006P, 5143M3HJ500001Y, 5143M3HJ500002J, 5143M3HJ500003A, 5143M3HJ500004M, 5143M3HJ500005P, 5143M3HJ500006W, 5143M3HJ600003K, 5143M3HJ600004J, 5143M3HJ600005D and 236 more |
| Model numbers | GM85 |
Product
Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
Reason for recall
Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to 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-1056-2024. 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.