Has GE Healthcare (China) Co., Ltd. had other FDA enforcement actions?

Yes. Argus HQ has recorded 24 total FDA actions tied to GE Healthcare (China) Co., Ltd.: 0 warning letters, 24 recalls, 0 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2024-12-11; Argus observed and indexed it on 2026-07-16.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · device_recall · high

GE Healthcare (China) Co., Ltd. — Class II recall: GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography syst…

Name: FDA Recall Record — GE Healthcare (China) Co., Ltd.
Creator: Argus HQ
Published: 2024-12-11
License: https://argushq.ai/methodology

Event date: 2024-12-11 00:00:00Z
Observed: 2026-07-16 23:20:10Z
Source ID: Z-0601-2025
Payload hash: c942d30dc427261e55a03fdf…

Summary

GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each… Status: Ongoing.

Entities

GE Healthcare (China) Co., Ltd.

View source record ↗

Frequently asked questions

Has GE Healthcare (China) Co., Ltd. had other FDA enforcement actions?: Yes. Argus HQ has recorded 24 total FDA actions tied to GE Healthcare (China) Co., Ltd.: 0 warning letters, 24 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2024-12-11; Argus observed and indexed it on 2026-07-16.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

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.

APA

Argus HQ Research (2024). GE Healthcare (China) Co., Ltd. — Class II recall: GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography syst…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-ge-healthcare-china-co-ltd-z-0601-2025

MLA

"GE Healthcare (China) Co., Ltd. — Class II recall: GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography syst…." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/events/fda-recall-ge-healthcare-china-co-ltd-z-0601-2025.

Chicago

Argus HQ Research. "GE Healthcare (China) Co., Ltd. — Class II recall: GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography syst…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-ge-healthcare-china-co-ltd-z-0601-2025.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_ge_healthcare_china_co_ltd_z_0601_2025_2024,
  title = {GE Healthcare (China) Co., Ltd. — Class II recall: GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography syst…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-ge-healthcare-china-co-ltd-z-0601-2025},
  note = {Accessed: July 17, 2026}
}

Informational only. Not legal, financial, or medical advice.