CLASS II Device recall · Reported 23 Jun 2021 · FDA Enforcement Report

Innova IGS 3 recalled by GE Healthcare

GE Healthcare is recalling Innova IGS 3 (, distributed nationwide in the US. The recall was initiated on 19 Apr 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAffected 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, 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: D4-21-009, M3-21-022, M3-21-008, B3-21-005, D3-21-003, M3-21-025, M2-20-044, M3-21-029 D3-20-027, M2-21-011, and M3-21-021.

Quantity recalled139 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1864-2021
FDA event ID: 87863
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 19 Apr 2021
FDA classified: 15 Jun 2021
Reported: 23 Jun 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

19 Apr 2021	Recall initiated by company
15 Jun 2021	Classified by FDA	+57 days
23 Jun 2021	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of CA, CO, FL, GA, KY, LA, MA, MO, MS, NC, NJ, NV, NY, PA, SC, TN, TX, VA, WA, and WI. Government distribution was made and potentially military distribution was made. The countries of Algeria, Argentina, Canada, China, Dominican Republic, Finland, France, Germany, Hungary, India, Indonesia, Iran, Iraq, Italy, Japan, Korea, Kuwait, Mexico, Moldova, Morocco, Poland, Russia, Spain, Sudan, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Uzbekistan.

Nationwide California Colorado Florida Georgia Kentucky Louisiana Massachusetts Missouri Mississippi North Carolina New Jersey Nevada New York Pennsylvania South Carolina Tennessee Texas Virginia Washington Wisconsin

Questions about this recall

Why was it 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.

Which lots are affected?

Affected 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, 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: D4-21-009, M3-21-022, M3-21-008, B3-21-005, D3-21-003, M3-21-025, M2-20-044, M3-21-029 D3-20-027, M2-21-011, and M3-21-021.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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