Lower riskMedical device recall · FDA · Published April 19, 2021
GE Healthcare Innova IGS 3/5/6 X-Ray Systems Have Display Line Defect
GE Healthcare recalls Innova IGS 3, 5, and 6 x-ray systems with a vertical line defect that splits monitor images. Affected units have specific serial numbers listed in the recall notice.
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.
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Contact the company
📍Recalling firmGE Healthcare, LLC3000 N Grandview Blvd · Waukesha, WI 53188-1615
✎ GovInfoNow plain-language explainer
GE Healthcare is recalling certain Innova IGS 3, 5, and 6 interventional fluoroscopic x-ray systems due to a vertical line defect that splits monitor images. This defect could cause inaccurate imaging during medical procedures. Read more at govinfonow.com/recall/62766-ge-healthcare-innova-igs-3-5-6-x-ray-systems.
“GE Healthcare Innova IGS 3/5/6 X-Ray Systems Have Display Line Defect.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62766-ge-healthcare-innova-igs-3-5-6-x-ray-systems. Based on FDA recall #Z-1864-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1864-2021%22&limit=1).
The Food and Drug Administration announced on April 19, 2021, that GE Healthcare LLC voluntarily recalled interventional fluoroscopic x-ray systems due to a potential vertical line defect on monitor displays. The recall affects 139 devices distributed worldwide.
How to tell if you have it
GE Healthcare Innova IGS 3 (GTIN 00840682147378)
GE Healthcare Innova IGS 5 (GTIN 00840682124621)
GE Healthcare Innova IGS 6 (GTIN 00840682124614)
GE Healthcare Discovery IGS 7 (GTIN 00840682124638)
GE Healthcare Discovery IGS 7 OR (GTIN 00840682125888)
The hazard
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.
Context
GovInfoNow's records show GE Healthcare LLC has 97 other recalls on record since October 4, 2017. Other recent recalls of similar products include GE Healthcare SIGNA Premier MRI Scanners (February 27, 2026), GE Centricity Universal Viewer 6.0/7.0/8.0 (July 15, 2022), and GE Healthcare SIGNA Premier MRI Scanner Recall (June 24, 2022). Other recent recalls of similar products include Philips Incisive CT Recall (December 3, 2025) and GE Optima XR200amx Mobile Radiography System Recall (June 5, 2026).
How to tell if you have this one
Check the serial numbers listed in the recall notice. Affected units include specific models (Innova IGS 3, 5, 6) with serial numbers starting with B2-, B3-, D3-, D4-, M2-, or M3-.
Brand
GE Healthcare
Product
GE Healthcare, LLC recalls GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Numbers
Compare your system's serial number against the list of affected serial numbers provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 20 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Florida, Georgia, Kentucky, Louisiana, Massachusetts, Mississippi, Missouri, Nevada, New Jersey, New York, North Carolina, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1864-2021 (April 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1864-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.