FDA action counts
| Total FDA actions | 15 |
|---|---|
| Warning letters | 0 |
| Recalls | 15 |
| Approval records | 0 |
| Form 483 inspection citations | 0 |
| Most recent action | June 24, 2026 |
Risk pattern analysis
Argus HQ analysis — not an FDA finding
This section is Argus HQ analysis, not an FDA finding. GE Medical Systems, LLC has 15 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.
Enforcement history
On 2026-05-20, Argus HQ recorded a FDA recall for GE Medical Systems, LLC, rated "high" severity in Argus HQ's classification: GE Medical Systems, LLC — Class II recall: Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-30… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-20, Argus HQ recorded a FDA recall for GE Medical Systems, LLC, rated "high" severity in Argus HQ's classification: GE Medical Systems, LLC — Class II recall: Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25 An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-20, Argus HQ recorded a FDA recall for GE Medical Systems, LLC, rated "high" severity in Argus HQ's classification: GE Medical Systems, LLC — Class II recall: Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15 An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-20, Argus HQ recorded a FDA recall for GE Medical Systems, LLC, rated "high" severity in Argus HQ's classification: GE Medical Systems, LLC — Class II recall: Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6 An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-20, Argus HQ recorded a FDA recall for GE Medical Systems, LLC, rated "high" severity in Argus HQ's classification: GE Medical Systems, LLC — Class II recall: Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23 An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-20, Argus HQ recorded a FDA recall for GE Medical Systems, LLC, rated "high" severity in Argus HQ's classification: GE Medical Systems, LLC — Class II recall: Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27 An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-20, Argus HQ recorded a FDA recall for GE Medical Systems, LLC, rated "high" severity in Argus HQ's classification: GE Medical Systems, LLC — Class II recall: Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20 An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-17, Argus HQ recorded a FDA recall for GE Medical Systems, LLC, rated "high" severity in Argus HQ's classification: GE Medical Systems, LLC — Class II recall: Allia IGS Pulse angiographic X-ray system An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-17, Argus HQ recorded a FDA recall for GE Medical Systems, LLC, rated "high" severity in Argus HQ's classification: GE Medical Systems, LLC — Class II recall: Allia Moveo angiographic X-ray system An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-17, Argus HQ recorded a FDA recall for GE Medical Systems, LLC, rated "high" severity.
Frequently asked questions
- What is the most recent FDA action against GE Medical Systems, LLC?
- The most recent FDA event Argus HQ has on file for GE Medical Systems, LLC is dated 2026-06-24, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
- Does Argus HQ track new FDA actions for GE Medical Systems, LLC automatically?
- Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to GE Medical Systems, LLC is observed, this page's event count and history update automatically.
- How many FDA actions does Argus HQ track for GE Medical Systems, LLC?
- 15 total: 0 warning letters, 15 recalls, 0 approval records, and 0 Form 483 inspection citations.
- What is the most recent FDA action on file for GE Medical Systems, LLC?
- June 24, 2026. Argus HQ ingests new FDA enforcement records daily.
Every FDA action tied to this company, the week it happens.
Free weekly briefing. Real-time alerts on paid plans.
Related enforcement actions
- GE Medical Systems, LLC — Class II recall: Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination… →
- GE Medical Systems, LLC — Class II recall: Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 66… →
- GE Medical Systems, LLC — Class II recall: Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All… →
- GE Medical Systems, LLC — Class II recall: Allia IGS 3 Pulse angiographic X-ray system →
- GE Medical Systems, LLC — Class II recall: Allia IGS 7 Pulse angiographic X-ray system →
- GE Medical Systems, LLC — Class II recall: Allia IGS 5 Pulse angiographic X-ray system →
- GE Medical Systems, LLC — Class II recall: Allia Moveo angiographic X-ray system →
- GE Medical Systems, LLC — Class II recall: Allia IGS Pulse angiographic X-ray system →
- GE Medical Systems, LLC — Class II recall: Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6 →
- GE Medical Systems, LLC — Class II recall: Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25 →
Compare with
Two different companies merged onto this page by mistake? Or a name variant missing? Tell us — corrections@argushq.ai
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Enforcement History: GE Medical Systems, LLC. Digital Empire LLC. Retrieved from https://argushq.ai/company/ge-medical-systems-llc
"FDA Enforcement History: GE Medical Systems, LLC." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/ge-medical-systems-llc.
Argus HQ Research. "FDA Enforcement History: GE Medical Systems, LLC." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/ge-medical-systems-llc.
@misc{argushq_argushq_ai_company_ge_medical_systems_llc_2026,
title = {FDA Enforcement History: GE Medical Systems, LLC},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/company/ge-medical-systems-llc},
note = {Accessed: July 13, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗