Has GE Healthcare GmbH had other FDA enforcement actions?

Yes. Argus HQ has recorded 3 total FDA actions tied to GE Healthcare GmbH: 0 warning letters, 3 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 2025-12-24; 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 GmbH — Class II recall: GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processin…

Name: FDA Recall Record — GE Healthcare GmbH
Creator: Argus HQ
Published: 2025-12-24
License: https://argushq.ai/methodology

Event date: 2025-12-24 00:00:00Z
Observed: 2026-07-16 23:20:10Z
Source ID: Z-0935-2026
Payload hash: 8e02466c78648280e813feb4…

Summary

GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information. Status: Ongoing.

Entities

GE Healthcare GmbH

View source record ↗

Frequently asked questions

Has GE Healthcare GmbH had other FDA enforcement actions?: Yes. Argus HQ has recorded 3 total FDA actions tied to GE Healthcare GmbH: 0 warning letters, 3 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 2025-12-24; 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 GmbH — Class II recall: GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processin…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-ge-healthcare-gmbh-z-0935-2026

MLA

"GE Healthcare GmbH — Class II recall: GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processin…." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/events/fda-recall-ge-healthcare-gmbh-z-0935-2026.

Chicago

Argus HQ Research. "GE Healthcare GmbH — Class II recall: GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processin…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-ge-healthcare-gmbh-z-0935-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_ge_healthcare_gmbh_z_0935_2026_2025,
  title = {GE Healthcare GmbH — Class II recall: GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processin…},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-ge-healthcare-gmbh-z-0935-2026},
  note = {Accessed: July 17, 2026}
}

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