FDA action counts
| Total FDA actions | 1 |
|---|---|
| Warning letters | 0 |
| Recalls | 1 |
| Approval records | 0 |
| Form 483 inspection citations | 0 |
| Most recent action | September 2, 2026 |
Enforcement history
On 2026-09-02, Argus HQ recorded an FDA recall for FUJIFILM Healthcare Americas Corporation, rated "high" severity in Argus HQ's classification: FUJIFILM Healthcare Americas Corporation — Class II recall: FUJIFILM Synapse PACS software v7.4.310; radiological image processing system. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.
Risk pattern analysis
Argus HQ analysis — not an FDA finding
This section is Argus HQ analysis, not an FDA finding. FUJIFILM Healthcare Americas Corporation has 1 FDA event on file. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
Frequently asked questions
- How many FDA actions does Argus HQ track for FUJIFILM Healthcare Americas Corporation?
- 1 total: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.
- What is the most recent FDA action on file for FUJIFILM Healthcare Americas Corporation?
- September 2, 2026. Argus HQ ingests new FDA enforcement records daily.
- Has FUJIFILM Healthcare Americas Corporation had product recalls?
- Yes, 1 recall on file. See the full history below for each one.
- Is this FDA enforcement data for FUJIFILM Healthcare Americas Corporation official?
- Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.
Every FDA action tied to this company, the week it happens.
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Related enforcement actions
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Two different companies merged onto this page by mistake? Or a name variant missing? Tell us — corrections@argushq.ai
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Verified from FDA.gov · Last updated: Sep 2, 2026Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Actions Against FUJIFILM Healthcare Americas Corporation. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/company/fujifilm-healthcare-americas-corporation
"FDA Actions Against FUJIFILM Healthcare Americas Corporation." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/company/fujifilm-healthcare-americas-corporation.
Argus HQ Research. "FDA Actions Against FUJIFILM Healthcare Americas Corporation." Digital Empire Holdings LLC. Accessed October 8, 2026. https://argushq.ai/company/fujifilm-healthcare-americas-corporation.
@misc{argushq_argushq_ai_company_fujifilm_healthcare_americas_corporation_2026,
title = {FDA Actions Against FUJIFILM Healthcare Americas Corporation},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/company/fujifilm-healthcare-americas-corporation},
note = {Accessed: October 8, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗