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fda_recall · device_recall · high

GE Healthcare (China) Co., Ltd. — Class II recall: GE Proteus XR/A radiographic system

Event date
2024-12-04 00:00:00Z
Observed
2026-07-16 23:20:10Z
Source ID
Z-0550-2025
Payload hash
4108ec4dd0ac859cb1c4143e

Summary

Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List. Status: Ongoing.

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 2024-12-04; 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 Proteus XR/A radiographic system. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-ge-healthcare-china-co-ltd-z-0550-2025
MLA
"GE Healthcare (China) Co., Ltd. — Class II recall: GE Proteus XR/A radiographic system." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/events/fda-recall-ge-healthcare-china-co-ltd-z-0550-2025.
Chicago
Argus HQ Research. "GE Healthcare (China) Co., Ltd. — Class II recall: GE Proteus XR/A radiographic system." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-ge-healthcare-china-co-ltd-z-0550-2025.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_ge_healthcare_china_co_ltd_z_0550_2025_2024,
  title = {GE Healthcare (China) Co., Ltd. — Class II recall: GE Proteus XR/A radiographic system},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-ge-healthcare-china-co-ltd-z-0550-2025},
  note = {Accessed: July 17, 2026}
}

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