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 2025-03-05; 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: Optima MR360, NMRI system

Name: FDA Recall Record — GE Healthcare (China) Co., Ltd.
Creator: Argus HQ
Published: 2025-03-05
License: https://argushq.ai/methodology

Event date: 2025-03-05 00:00:00Z
Observed: 2026-07-16 23:20:10Z
Source ID: Z-1241-2025
Payload hash: 0113e5289c673ceeb475cee2…

Summary

For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in pot… 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 2025-03-05; 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 (2025). GE Healthcare (China) Co., Ltd. — Class II recall: Optima MR360, NMRI system. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-ge-healthcare-china-co-ltd-z-1241-2025

MLA

"GE Healthcare (China) Co., Ltd. — Class II recall: Optima MR360, NMRI system." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/events/fda-recall-ge-healthcare-china-co-ltd-z-1241-2025.

Chicago

Argus HQ Research. "GE Healthcare (China) Co., Ltd. — Class II recall: Optima MR360, NMRI system." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-ge-healthcare-china-co-ltd-z-1241-2025.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_ge_healthcare_china_co_ltd_z_1241_2025_2025,
  title = {GE Healthcare (China) Co., Ltd. — Class II recall: Optima MR360, NMRI system},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-ge-healthcare-china-co-ltd-z-1241-2025},
  note = {Accessed: July 17, 2026}
}

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