GE Healthcare Innova IGS 3 — Class II medical device recall Z-1864-2021
Terminated recall by GE Healthcare, LLC, reported 2021-06-23, distributed nationwide. The IGS system can experience a single vertical line defect where the vertical line divides and horizontally s
| Recall number | Z-1864-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2021-04-19 |
| Classified | 2021-06-15 |
| Reported by FDA | 2021-06-23 |
| Terminated | 2023-08-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, CA, CN, DE, DO, DZ, ES, FI, FR, GB, HU, ID, IN, IQ, IR, IT, JP, KR, KW, MA, MX, PL, RU, TR, TW |
| Quantity | 139 devices |
| UPC / GTIN / UDI-DI | 00840682124614, 00840682124621, 00840682124638, 00840682125888, 00840682147378 |
| Serial numbers | B2-20-006, B2-20-007, B2-20-008, B2-20-009, B2-21-001, B3-20-024, B3-20-026, B3-20-027, B3-20-028, B3-21-001, B3-21-002, B3-21-003, B3-21-006, D3-20-025, D3-20-028, D3-20-029, D3-21-002, D3-21-005, D3-21-006, D3-21-007, D3-21-008, D3-21-009, D4-20-025, D4-20-026, D4-20-029 and 99 more |
Product
GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840682124638), and Discovery IGS 7 OR (GTIN00840682125888) interventional fluoroscopic x-ray systems.
Reason for recall
The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image parts within the monitor display screen.
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-1864-2021. 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.