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fda_recall · device_recall · high

GE Healthcare LLC — Class II recall: SIGNA Premier systems

Event date
2026-04-08 00:00:00Z
Observed
2026-07-16 23:20:10Z
Source ID
Z-1767-2026
Payload hash
58574659c0ee7bc8a6de4887

Summary

Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramp… Status: Ongoing.

Frequently asked questions

Has GE Healthcare LLC had other FDA enforcement actions?
This is the only FDA action Argus HQ has on file for GE Healthcare LLC as of 2026-07-16. Argus ingests new FDA enforcement records daily.
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 2026-04-08; 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 (2026). GE Healthcare LLC — Class II recall: SIGNA Premier systems. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-ge-healthcare-llc-z-1767-2026
MLA
"GE Healthcare LLC — Class II recall: SIGNA Premier systems." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/events/fda-recall-ge-healthcare-llc-z-1767-2026.
Chicago
Argus HQ Research. "GE Healthcare LLC — Class II recall: SIGNA Premier systems." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-ge-healthcare-llc-z-1767-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_ge_healthcare_llc_z_1767_2026_2026,
  title = {GE Healthcare LLC — Class II recall: SIGNA Premier systems},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-ge-healthcare-llc-z-1767-2026},
  note = {Accessed: July 17, 2026}
}

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