GM85 Digital Mobile X-ray imaging System — Class II medical device recall Z-0480-2026
Ongoing recall by NeuroLogica Corporation, reported 2025-11-19, distributed nationwide. The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal
| Recall number | Z-0480-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | NeuroLogica Corporation, Danvers, MA, United States |
| Recall initiated | 2025-10-07 |
| Classified | 2025-11-07 |
| Reported by FDA | 2025-11-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CH, CL, CN, CZ, DE, DK, EC, ES, FI, FR, GB, GH, HU, IN, IT, KR, MX, MY, NL, NO, NZ, PE, PH, PL, PT, RS, SA, SE, SG, TH, VN |
| Quantity | 236 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 08806088582412 |
| Serial numbers | 513YM3IJA00001X, 513YM3IK100002D, 513YM3IK100003N, 513YM3IK400001W, 513YM3IK400002A, 513YM3IK500001K, 513YM3IK500002R, 513YM3IK500003Z, 513YM3IK500004H, 513YM3IK500005Y, 5143M3DHB00001M, 5143M3GK500001H, 5143M3GK500002Y, 5143M3GK500003J, 5143M3GK500004A, 5143M3GK500005M, 5143M3GK500006P, 5143M3GK500007W, 5143M3HJ500001Y, 5143M3HJ500002J, 5143M3HJ500003A, 5143M3HJ500004M, 5143M3HJ500006W, 5143M3HJ600003K, 5143M3HJ600005D and 211 more |
| Model numbers | GM85 |
Product
GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
Reason for recall
The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.
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-0480-2026. 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.