GE Healthcare Innova IGS 6 — Class II medical device recall Z-1778-2024
Ongoing recall by GE Medical Systems, SCS, reported 2024-05-15, distributed nationwide. GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bol
| Recall number | Z-1778-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems, SCS, Buc, N/A, France |
| Recall initiated | 2024-03-18 |
| Classified | 2024-05-06 |
| Reported by FDA | 2024-05-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, ES, FR, HU, IN, IT, JP, LT, MX, RU, TR, TW, VN |
| Quantity | 3 units |
| UPC / GTIN / UDI-DI | 00840682124614 |
| Serial numbers | B3-23-015, B3-23-016, B3-24-002 |
Product
GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems
Reason for recall
GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
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-1778-2024. 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.