Has GE Healthcare Finland Oy had other FDA enforcement actions?

Yes. Argus HQ has recorded 19 total FDA actions tied to GE Healthcare Finland Oy: 0 warning letters, 19 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 critical severity by Argus HQ. FDA published the underlying record on 2023-07-12; 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 · critical

GE Healthcare Finland Oy — Class I recall: TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oxi…

Name: FDA Recall Record — GE Healthcare Finland Oy
Creator: Argus HQ
Published: 2023-07-12
License: https://argushq.ai/methodology

Event date: 2023-07-12 00:00:00Z
Observed: 2026-07-16 23:20:10Z
Source ID: Z-2027-2023
Payload hash: 7269f469745f1b881feb968e…

Summary

There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. Status: Ongoing.

Entities

GE Healthcare Finland Oy

View source record ↗

Frequently asked questions

Has GE Healthcare Finland Oy had other FDA enforcement actions?: Yes. Argus HQ has recorded 19 total FDA actions tied to GE Healthcare Finland Oy: 0 warning letters, 19 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 critical severity by Argus HQ. FDA published the underlying record on 2023-07-12; 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 Finland Oy — Class I recall: TruSignal AllFit Sensor:    a) REF TS-AF-10, 10 pcs;   B) REF AF-25, 25 pcs; Oxi…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-ge-healthcare-finland-oy-z-2027-2023

MLA

"GE Healthcare Finland Oy — Class I recall: TruSignal AllFit Sensor:    a) REF TS-AF-10, 10 pcs;   B) REF AF-25, 25 pcs; Oxi…." Argus HQ Research, Digital Empire LLC, 2023, argushq.ai/events/fda-recall-ge-healthcare-finland-oy-z-2027-2023.

Chicago

Argus HQ Research. "GE Healthcare Finland Oy — Class I recall: TruSignal AllFit Sensor:    a) REF TS-AF-10, 10 pcs;   B) REF AF-25, 25 pcs; Oxi…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-ge-healthcare-finland-oy-z-2027-2023.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_ge_healthcare_finland_oy_z_2027_2023_2023,
  title = {GE Healthcare Finland Oy — Class I recall: TruSignal AllFit Sensor:    a) REF TS-AF-10, 10 pcs;   B) REF AF-25, 25 pcs; Oxi…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-ge-healthcare-finland-oy-z-2027-2023},
  note = {Accessed: July 17, 2026}
}

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