Reported Jun 23, 2021 · Terminated
GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- 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.
- Lot codes and dates
- Affected serial numbersB2-20-006, 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, D4-20-031, D4-20-032, D4-20-033, D4-21-003, D4-21-004, D4-21-005, D4-21-007, D4-21-008, D4-21-010, M2-20-040, M2-20-041, M2-20-042, M2-20-043, M2-20-045, M2-20-046, M2-20-047, M2-20-048, M2-20-049, M2-20-050, M2-20-051, M2-20-052, M2-20-053, M2-20-054, M2-21-003, M2-21-004, M2-21-005, M2-21-006, M2-21-007, M2-21-008, M2-21-009, M2-21-010, M2-21-012, M2-21-013, M2-21-014, M3-20-094, M3-20-095, M3-20-096, M3-20-098, M3-20-101, M3-20-105, M3-20-108, M3-20-110, M3-20-114, M3-20-116, M3-20-118, M3-20-119, M3-20-120, M3-20-122, M3-20-123, M3-20-124, M3-20-125, M3-20-126, M3-20-127, M3-21-001, M3-21-006, M3-21-007, M3-21-009, M3-21-010, M3-21-011, M3-21-012, M3-21-013, M3-21-014, M3-21-015, M3-21-016, M3-21-017, M3-21-019, M3-21-020, M3-21-023, M3-21-024, M3-21-026, M3-21-027, M3-21-028, M4-20-022, M4-20-023, M4-20-026, M4-20-028, M4-20-029, M4-20-030, M4-20-033, M4-20-034, M4-20-035, M4-20-036, M4-20-039, M4-20-041, M4-21-001, M4-21-002, M4-21-004, M4-21-005, M4-21-006, M4-21-007, M4-21-008, M4-21-009, M4-21-011, M4-21-012, M4-21-013, M4-21-014, M4-21-015, M4-21-016, and M4-21-017. Serial numbers that are under GE control but are consigned
- to a facility and not yet installed
D4-21-009M3-21-022M3-21-008B3-21-005D3-21-003M3-21-025M2-20-044M3-21-029 D3-20-027M2-21-011and M3-21-021
- Amount recalled
- 139 devices
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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