Has Shimadzu Medical Systems had product recalls?

Yes, 1 recall on file. See the full history below for each one.

Is this FDA enforcement data for Shimadzu Medical Systems 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.

How many FDA actions has Shimadzu Medical Systems had?

Argus HQ has recorded 1 FDA events for Shimadzu Medical Systems: 0 warning letters, 1 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

What is the most recent FDA action against Shimadzu Medical Systems?

The most recent FDA event Argus HQ has on file for Shimadzu Medical Systems is dated 2026-06-10, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Regulatory Record: Shimadzu Medical Systems

FDA action counts

Total FDA actions	1
Warning letters	0
Recalls	1
Approval records	0
Form 483 inspection citations	0
Most recent action	June 10, 2026

The short version: Argus HQ has recorded 1 FDA events for Shimadzu Medical Systems: 0 warning letters, 1 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2026-06-10 to 2026-06-10. The most severe rating Argus HQ has assigned across this history is "high". 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. Shimadzu Medical Systems 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.

Enforcement history

On 2026-06-10, Argus HQ recorded an FDA recall for Shimadzu Medical Systems, rated "high" severity in Argus HQ's classification: Shimadzu Medical Systems — Class II recall: Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography Sy…. 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.

Frequently asked questions

Has Shimadzu Medical Systems had product recalls?: Yes, 1 recall on file. See the full history below for each one.
Is this FDA enforcement data for Shimadzu Medical Systems 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.
How many FDA actions has Shimadzu Medical Systems had?: Argus HQ has recorded 1 FDA events for Shimadzu Medical Systems: 0 warning letters, 1 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
What is the most recent FDA action against Shimadzu Medical Systems?: The most recent FDA event Argus HQ has on file for Shimadzu Medical Systems is dated 2026-06-10, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Every FDA action tied to this company, the week it happens.

Free weekly briefing. Real-time alerts on paid plans.

Shimadzu Medical Systems — Class II recall: Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography Sy… →

Compare with

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

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Regulatory Record: Shimadzu Medical Systems. Digital Empire LLC. Retrieved from https://argushq.ai/company/shimadzu-medical-systems

MLA

"Regulatory Record: Shimadzu Medical Systems." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/shimadzu-medical-systems.

Chicago

Argus HQ Research. "Regulatory Record: Shimadzu Medical Systems." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/shimadzu-medical-systems.

BibTeX

@misc{argushq_argushq_ai_company_shimadzu_medical_systems_2026,
  title = {Regulatory Record: Shimadzu Medical Systems},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/company/shimadzu-medical-systems},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗