How many FDA warning letters has Elekta, Inc. received?

Argus HQ has not recorded an FDA warning letter for Elekta, Inc. in our current dataset.

What FDA recalls has Elekta, Inc. issued?

Argus HQ has recorded 2 FDA recalls tied to Elekta, Inc..

Is Elekta, Inc. FDA compliant?

Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 2 recalls, and 0 approval records for Elekta, Inc.. Review the linked FDA source records directly before drawing a compliance conclusion.

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company

Elekta, Inc.

Name: FDA Enforcement Actions Against Elekta, Inc.
Creator: Argus HQ
License: https://argushq.ai/methodology

Jurisdiction: US

FDA Warning Letter timeline

V1 scope: FDA Warning Letters only. Additional public-record sources (SEC, CPSC, federal contracts) are on the V2 roadmap and are not surfaced here today.

fda_recall · device_recall2026-06-17
Elekta, Inc. — Class II recall: MOSAIQ Oncology Information System
fda_recall · device_recall2026-05-06
Elekta, Inc. — Class II recall: Brand Name: Leksell Vantage Arc System REF: 1053958

Frequently asked questions

How many FDA warning letters has Elekta, Inc. received?: Argus HQ has not recorded an FDA warning letter for Elekta, Inc. in our current dataset.
What FDA recalls has Elekta, Inc. issued?: Argus HQ has recorded 2 FDA recalls tied to Elekta, Inc..
Is Elekta, Inc. FDA compliant?: Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 2 recalls, and 0 approval records for Elekta, Inc.. Review the linked FDA source records directly before drawing a compliance conclusion.

Informational only. FDA Warning Letters are public records (17 USC §105). Summaries are AI-assisted and may contain errors; always verify against the original FDA letter before acting. Not legal, financial, or regulatory advice.