Has GE Healthcare had other FDA enforcement actions?

Yes. Argus HQ has recorded 18 total FDA actions tied to GE Healthcare: 0 warning letters, 18 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 2023-11-01; 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 — Class II recall: Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological I…

Name: FDA Recall Record — GE Healthcare
Creator: Argus HQ
Published: 2023-11-01
License: https://argushq.ai/methodology

Event date: 2023-11-01 00:00:00Z
Observed: 2026-07-16 23:20:10Z
Source ID: Z-0138-2024
Payload hash: af6454de0240786eebcea6fd…

Summary

GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation. Status: Ongoing.

Entities

GE Healthcare

View source record ↗

Frequently asked questions

Has GE Healthcare had other FDA enforcement actions?: Yes. Argus HQ has recorded 18 total FDA actions tied to GE Healthcare: 0 warning letters, 18 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 2023-11-01; 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 (2023). GE Healthcare — Class II recall: Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological I…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-ge-healthcare-z-0138-2024

MLA

"GE Healthcare — Class II recall: Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological I…." Argus HQ Research, Digital Empire LLC, 2023, argushq.ai/events/fda-recall-ge-healthcare-z-0138-2024.

Chicago

Argus HQ Research. "GE Healthcare — Class II recall: Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological I…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-ge-healthcare-z-0138-2024.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_ge_healthcare_z_0138_2024_2023,
  title = {GE Healthcare — Class II recall: Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological I…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-ge-healthcare-z-0138-2024},
  note = {Accessed: July 17, 2026}
}

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