Has Accuray Incorporated had other FDA enforcement actions?

Yes. Argus HQ has recorded 2 total FDA actions tied to Accuray Incorporated: 0 warning letters, 2 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 2026-07-08; Argus observed and indexed it on 2026-07-14.

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 · high

Accuray Incorporated — Class II recall: Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator…

Name: FDA Recall Record — Accuray Incorporated
Creator: Argus HQ
Published: 2026-07-08
License: https://argushq.ai/methodology

Event date: 2026-07-08 00:00:00Z
Observed: 2026-07-14 04:20:22Z
Source ID: Z-2644-2026
Payload hash: 0a8192567da8dd343470364d…

Summary

In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing. Status: Ongoing.

Entities

Accuray Incorporated

View source record ↗

Frequently asked questions

Has Accuray Incorporated had other FDA enforcement actions?: Yes. Argus HQ has recorded 2 total FDA actions tied to Accuray Incorporated: 0 warning letters, 2 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 2026-07-08; Argus observed and indexed it on 2026-07-14.
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). Accuray Incorporated — Class II recall: Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-accuray-incorporated-z-2644-2026

MLA

"Accuray Incorporated — Class II recall: Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator…." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/events/fda-recall-accuray-incorporated-z-2644-2026.

Chicago

Argus HQ Research. "Accuray Incorporated — Class II recall: Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator…." Digital Empire LLC. Accessed July 14, 2026. https://argushq.ai/events/fda-recall-accuray-incorporated-z-2644-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_accuray_incorporated_z_2644_2026_2026,
  title = {Accuray Incorporated — Class II recall: Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-accuray-incorporated-z-2644-2026},
  note = {Accessed: July 14, 2026}
}

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