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fda_recall · device_recall · high

GE Medical Systems, LLC — Class II recall: Optima XR220amx, Mobile Digital-Ready Radiographic System

Event date
2026-07-22 00:00:00Z
Observed
2026-07-28 04:20:56Z
Source ID
Z-2727-2026
Payload hash
02938423498c5a0bf759634f…

Summary

GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechani… Status: Ongoing.

Entities

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Frequently asked questions

Has GE Medical Systems, LLC had other FDA enforcement actions?
Yes. Argus HQ has recorded 18 total FDA actions tied to GE Medical Systems, LLC: 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 2026-07-22; Argus observed and indexed it on 2026-07-28.
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, LLC — Class II recall: Optima XR220amx, Mobile Digital-Ready Radiographic System. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-ge-medical-systems-llc-z-2727-2026
MLA
"GE Medical Systems, LLC — Class II recall: Optima XR220amx, Mobile Digital-Ready Radiographic System." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-ge-medical-systems-llc-z-2727-2026.
Chicago
Argus HQ Research. "GE Medical Systems, LLC — Class II recall: Optima XR220amx, Mobile Digital-Ready Radiographic System." Digital Empire Holdings LLC. Accessed July 28, 2026. https://argushq.ai/events/fda-recall-ge-medical-systems-llc-z-2727-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_ge_medical_systems_llc_z_2727_2026_2026,
  title = {GE Medical Systems, LLC — Class II recall: Optima XR220amx, Mobile Digital-Ready Radiographic System},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-ge-medical-systems-llc-z-2727-2026},
  note = {Accessed: July 28, 2026}
}

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

GE Medical Systems, LLC — Class II recall: Optima XR220amx, Mobile Digital-Ready Radiographic System · Argus HQ