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fda_recall · device_recall · high

GE HEALTHCARE AUSTRIA GMBH & CO — Class II recall: GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultra…

Event date
2024-02-07 00:00:00Z
Observed
2026-07-16 23:20:10Z
Source ID
Z-0865-2024
Payload hash
dec489e8f31b4adf9dd750b2

Summary

GE HealthCare has become aware of an issue with certain IC9-RS ultrasound probes (see Affected Products List) that can result in a double image artifact creating a ghost image with realistic features. An unrecognized artifact may lead to misdiagnosis. Status: Ongoing.

Frequently asked questions

Has GE HEALTHCARE AUSTRIA GMBH & CO had other FDA enforcement actions?
This is the only FDA action Argus HQ has on file for GE HEALTHCARE AUSTRIA GMBH & CO 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 2024-02-07; 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 (2024). GE HEALTHCARE AUSTRIA GMBH & CO — Class II recall: GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ,  Diagnostic ultra…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-ge-healthcare-austria-gmbh-and-co-z-0865-2024
MLA
"GE HEALTHCARE AUSTRIA GMBH & CO — Class II recall: GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ,  Diagnostic ultra…." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/events/fda-recall-ge-healthcare-austria-gmbh-and-co-z-0865-2024.
Chicago
Argus HQ Research. "GE HEALTHCARE AUSTRIA GMBH & CO — Class II recall: GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ,  Diagnostic ultra…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-ge-healthcare-austria-gmbh-and-co-z-0865-2024.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_ge_healthcare_austria_gmbh_and_co_z_0865_2024_2024,
  title = {GE HEALTHCARE AUSTRIA GMBH & CO — Class II recall: GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ,  Diagnostic ultra…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-ge-healthcare-austria-gmbh-and-co-z-0865-2024},
  note = {Accessed: July 17, 2026}
}

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