Use caution Medical device recall · FDA · Published March 29, 2018

GE Medical Systems Innova IGS X-ray Systems Recall: X-ray Abort Errors Risk Imaging Loss

GE Medical Systems recalls Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems due to potential X-ray abort errors causing imaging loss during procedures. Affected units have specific model and lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2387-2018Medical device GE Medical Systems ›

Use caution until it’s fixed

The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use.

Take action

Contact the company

Recalling firmGE Medical Systems, SCS283 rue de la Miniere · Buc, France

✎ GovInfoNow plain-language explainer

GE Medical Systems is recalling certain Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems because they may experience X-ray abort errors that could cause imaging to stop unexpectedly during use. This risk could lead to incomplete procedures or safety issues for medical staff and patients. Read more at govinfonow.com/recall/71575-ge-medical-systems-innova-igs-x-ray-systems-recall-x.

Source Summary by GovInfoNow · govinfonow.com/recall/71575-ge-medical-systems-innova-igs-x-ray-systems-recall-x · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2387-2018

Cite this page

“GE Medical Systems Innova IGS X-ray Systems Recall: X-ray Abort Errors Risk Imaging Loss.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71575-ge-medical-systems-innova-igs-x-ray-systems-recall-x. Based on FDA recall #Z-2387-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2387-2018%22&limit=1).

GE Medical Systems SCS voluntarily recalled Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems on March 29, 2018, according to the FDA. The devices may experience X-ray abort errors that could result in the loss of imaging mode before or during fluoroscopic use.

How to tell if you have it

Innova IGS 630, Model Number 5730860
Innova IGS 520, Model Number 5731194
Innova IGS 530, Model Number 5731195
Innova IGS 540, Model Number 5731196

The hazard

The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use.

Context

GovInfoNow's records show GE Medical Systems SCS has 4 other recalls on record since 2023-12-26. Other recent recalls of similar products include GE Healthcare Allia IGS 7 OR X-ray Systems Recall (2024-03-18) and GE Optima XR200amx Mobile Radiography System Recall (2026-06-05).

How to tell if you have this one

Check if your system has the Innova IGS 630, 520, 530, or 540 model with specific lot numbers listed in the recall notice. The model numbers and system IDs are provided in the detailed list.

Brand
GE Medical Systems
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
US distribution: AR, CA, CA, FL, GA, IA, IL, NC, NH, NJ, NM, NY, PA, SC, TN, A,WI, WV. International Distribution: Argentina, Brazil, China, Colombia, Egypt, France, India, Indonesia, Iran, Italy, Japan, Kuwait, Lithuania, Myanmar, Palestine, Poland, Russia, Saudi Arabia, Singapore, Spain, Tunisia, Turkey, United Kingdom, Vietnam.

Recall number	Product, codes & lots
Z-2386-2018	Discovery IGS 730 Interventional Fluoroscopic X-ray Systems; Model Number 5730890, Serial Numbers (System ID): 00000D3-17-030 (904BHHCHY), 00000D3-17-032 (083172440628), 661327IGS730 (00000D3-18-001), GON4598369 (00000D3-18-004), 082416140028 (00000D3-17-025), M4234253 (00000D3-17-028), YV3601 (00000D3-18-005), 6073XR0058 (00000D3-17-031).
Z-2387-2018	Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems; a. Innova IGS 630, Model Number 5730860 - Lot Number (System ID): 00000B3-18-001 (401BIPLANE1), 00000B3-17-032 (505841CATH3), 00000B3-17-029 (956632IGS630), 00000B3-17-030 (YV4502), 00000B3-18-002 (941629IGS630), 00000B3-17-031 (082416160071), 00000B3-18-003 (GON 4601349); b. Innova IGS 520, Model Number 5731194 - Lot Number (System ID): 00000M2-18-008 (410337CATH3), 00000M2-17-090 (603663DIGS), 00000M2-17-088 (603433IGS520), 00000M2-18-004 (423493CATH1), 00000M2-18-002 (414649IGS5), 00000M2-18-003 (414649IGS6), 00000M2-17-087 (M2505310), 00000M2-18-009 (00197VAS02), 00000M2-17-091 (082416040075), 00000M2-18-012 (GON 4607591), 00000M2-18-007 (GON 4607578), 00000M2-18-010 (GON 4607585), 00000M2-18-018 (GON 4592554), 00000M2-17-089 (083016866794118), 00000M2-18-001 (083016865380618), 00000M2-18-005 (GON 4608047), 00000M2-18-019 (GON 4596530), 00000M2-18-013 (GON 4610633), 00000M2-17-092 (A5187111), 00000M2-18-015 (FEG51905), 00000M2-18-006 (GON 4588912); c. Innova IGS 530, Model Number 5731195 - Lot Number (System ID): 00000M3-17-146 (479441CV4), 00000M3-18-007 (352726CATH1), 00000M3-17-136 (815759MCHCAR1), 00000M3-17-137 (856342INIGS), 00000M3-17-132 (856342IGS), 00000M3-17-148 (724658IGS530), 00000M3-18-004 (864573CL1), 00000M3-17-144 (901516INIGS), 00000M3-18-016 (GON 4480942), 00000M3-17-143 (304256INGS), 00000M3-18-005 (XV7945AR), 00000M3-18-005 (GON 1589001), 00000M3-18-011 (GON 1599555), 00000M3-17-150 (XVM317150), 00000M3-17-150 (4555829XV11), 00000M3-18-009 (GON 4603874), 00000M3-18-006 (XV709531BU8), 00000M3-18-003 (GON 4587457), 00000M3-18-003 (XVM3-18-003), 00000M3-18-023 (082416110059), 00000M3-17-135 (082416160068), 00000M3-18-018 (082416120077), 00000M3-17-142 (082416120092), 00000M3-17-152 (082416030051), 00000M3-18-024 (GON 4619686), 00000M3-18-022 (GON 4615780), 00000M3-17-140 (082416160075), 00000M3-17-139 (082416100140), 00000M3-18-021 (GON 4611356), 00000M3-17-141 (082416090100), 00000M3-17-145 (082416100152), 00000M3-18-020 (082416140030), 00000M3-18-017 (082416230041), 00000M3-17-134 (082416250025), 00000M3-17-151 (082416250024), 00000M3-17-133 (082416270031), 00000M3-18-008 (GON 4537575), 00000M3-17-147 (083016246178617), 00000M3-17-154 (5973XR0127), 00000M3-17-153 (5512XR0234), 00000M3-18-013 (GON 4601349), 00000M3-18-015 (GON 4604677), 00000M3-18-002 (6073XR0067), 00000M3-18-012 (GON 4496858), 00000M3-18-001 (RU1079VA01), 00000M3-17-149 (16055VAS01), 00000M3-17-138 (5973XR0121), 00000M3-17-155 (5973XR0112); d. Innova IGS 540 Model Number 5731196- Lot Number (System ID): 00000M4-17-053 (0770385IGS540), 00000M4-18-001 (716631INNOVAIGS), 00000M4-17-052 (215481IGS1), 00000M4-18-002 (215949IGS1), 00000M4-18-004 (843792IGS540), 00000M4-17-048 (253874IR), 00000M4-18-003 (GON 4537782), 00000M4-17-049 (082416040090), 00000M4-18-005 (GON 4619684), 00000M4-17-047 (082416240024), 00000M4-17-050 (082416100144), 00000M4-17-051 (PL1107VA05)
Z-2388-2018	Discovery IGS 740 Interventional Fluoroscopic X-ray Systems; Model Number 5730891- Lot Number (System ID): 00000D4-17-029 (478765NSP), 00000D4-17-031 (712279DIS), 00000D4-17-030 (716845DISC), 00000D4-18-003 (951TVHDISC740), 00000D4-18-001 (352751DISC), 00000D4-17-032 (SA1011VA02); Model Number 5759342 - 00000D4-17-028 (GON 4610398).

Based on the official FDA remedy

What to do — step by step

Check System Status
Verify if your system has the specific model numbers and lot numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed in 16 states, and outside the U.S.

FDA distribution: “US distribution: AR, CA, CA, FL, GA, IA, IL, NC, NH, NJ, NM, NY, PA, SC, TN, A,WI, WV. International Distribution: Argentina, Brazil, China, Colombia, Egypt, France, India, Indonesia, Iran, Italy, Japan, Kuwait, Lithuania, Myanmar,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arkansas, California, Florida, Georgia, Illinois, Iowa, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Pennsylvania, South Carolina, Tennessee, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 3.2 years after the firm started it.

Mar 29, 2018Firm started the recall
Jul 6, 2018FDA classified it Class II
Jul 18, 2018Published in FDA’s Enforcement Report
Jun 15, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/71575-ge-medical-systems-innova-igs-x-ray-systems-recall-x">GE Medical Systems Innova IGS X-ray Systems Recall: X-ray Abort Errors Risk Imaging Loss (GovInfoNow)</a>

Where this comes from

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-2387-2018 (March 29, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2387-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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.