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fda_recall · device_recall · high

GE Medical Systems Information Technologies Inc — Class II recall: FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 570022…

Event date
2026-09-02 00:00:00Z
Observed
2026-09-08 04:20:27Z
Source ID
Z-3039-2026
Payload hash
f011a4e4c83954ad5fcf36a8

Summary

Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area. Status: Ongoing.

Frequently asked questions

Has GE Medical Systems Information Technologies Inc had other FDA enforcement actions?
Yes. Argus HQ has recorded 13 total FDA actions tied to GE Medical Systems Information Technologies Inc: 0 warning letters, 13 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 2026-09-02; Argus observed and indexed it on 2026-09-08.
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 (2026). GE Medical Systems Information Technologies Inc — Class II recall: FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 570022…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-ge-medical-systems-information-technologies-inc-z-3039-2026
MLA
"GE Medical Systems Information Technologies Inc — Class II recall: FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 570022…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-ge-medical-systems-information-technologies-inc-z-3039-2026.
Chicago
Argus HQ Research. "GE Medical Systems Information Technologies Inc — Class II recall: FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 570022…." Digital Empire Holdings LLC. Accessed September 8, 2026. https://argushq.ai/events/fda-recall-ge-medical-systems-information-technologies-inc-z-3039-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_ge_medical_systems_information_technologies_inc_z_3039_2026_2026,
  title = {GE Medical Systems Information Technologies Inc — Class II recall: FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 570022…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-ge-medical-systems-information-technologies-inc-z-3039-2026},
  note = {Accessed: September 8, 2026}
}

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