GE Healthcare, LLC: Medical Device Recall in 2021 - (Recall #: Z-1864-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 19, 2021

Date Posted: June 23, 2021

Recall Number: Z-1864-2021

Event ID: 87863

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.

Status: Terminated

Product Quantity: 139 devices

Code Information:

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated