GE Healthcare, LLC: 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.

Recall number

Z-1864-2021

Recalling firm

GE Healthcare, LLC

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.

Status

Terminated

Initiated

2021-04-19

Posted

2021-06-15

Terminated

2023-08-31

Reason

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.

Root cause

Component change control

Action

The recalling firm issued letters dated 4/19/2021 via traceable mail on 4/20/21 and issued an additional letter dated 4/28/2021 to correct an omission of serial numbers (only sent to the affected consignees).

Quantity

139 devices

Distribution

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.

Lot, serial or model codes

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.

510(k) numbers

["K181403"]

PMA numbers

not on file

Product code

OWB

Firm FEI

2126677

Firm city

Waukesha

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy