FDA action counts (Argus HQ database)
| Total tracked FDA actions | 15 |
|---|---|
| Recalls | 15 |
| Warning letters | 0 |
| Form 483 inspection citations | 0 |
| Most recent tracked action | June 24, 2026 |
| Most severe rating on file | high |
Recall severity breakdown
Computed from all 15 tracked recalls. FDA classifies each recall Class I (most serious), II, or III on the underlying record; Argus HQ maps that to critical/high/medium/low severity buckets.
| high | 15 (100.0%) |
|---|
Recall velocity by month
Months with at least one tracked recall for GE Medical Systems, LLC, oldest to most recent. Gaps indicate months with zero tracked recalls, not missing data.
| Month | Recalls |
|---|---|
| 2026-05 | 7 |
| 2026-06 | 8 |
Recurring recall-reason patterns
Argus HQ keyword-matched the free-text “reason for recall” field on each tracked record into categories below. FDA does not publish a structured reason code for device recalls, so this is Argus HQ’s own pattern analysis, not an official FDA classification — records that don’t match a listed keyword fall into “Other.”
| Other / not pattern-matched | 15 recalls |
|---|
Full recall history (15)
Most recent first. Every row links to its Argus HQ record and FDA.gov source.
Coverage
No independent news coverage was found for GE Medical Systems, LLC’s FDA recall history at the time this page was published — its enforcement record is small enough that it hasn’t drawn trade-press attention. This page is the most complete public record available.
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Related enforcement actions
Full FDA history for GE Medical Systems, LLC- 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 Carestations and Giraffe OmniBed Carestation CS1, a combination… →
- 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 Apex, X-ray Computed Tomography, Model Number 5590000-20 →
- GE Medical Systems, LLC — Class II recall: Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27 →
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- Wells Pharma of Houston LLC: FDA enforcement history →
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- Amgen, Inc.: FDA enforcement history →
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Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Verified from FDA.gov · Last updated: Jun 24, 2026Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). GE Medical Systems, LLC: FDA Enforcement History. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/enforcement/ge-medical-systems-llc
"GE Medical Systems, LLC: FDA Enforcement History." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/enforcement/ge-medical-systems-llc.
Argus HQ Research. "GE Medical Systems, LLC: FDA Enforcement History." Digital Empire Holdings LLC. Accessed July 24, 2026. https://argushq.ai/enforcement/ge-medical-systems-llc.
@misc{argushq_argushq_ai_enforcement_ge_medical_systems_llc_2026,
title = {GE Medical Systems, LLC: FDA Enforcement History},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/enforcement/ge-medical-systems-llc},
note = {Accessed: July 24, 2026}
}