Has PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. had other FDA enforcement actions?

Yes. Argus HQ has recorded 199 total FDA actions tied to PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: 0 warning letters, 199 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 2025-05-14; 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.

.hq

fda_recall · device_recall · high

Philips Medical Systems Nederland B.V. — Class II recall: IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 8…

Name: FDA Recall Record — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Creator: Argus HQ
Published: 2025-05-14
License: https://argushq.ai/methodology

Event date: 2025-05-14 00:00:00Z
Observed: 2026-07-16 23:20:10Z
Source ID: Z-1740-2025
Payload hash: d2f00de9e0fa46a81444b4f3…

Summary

An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report. Status: Ongoing.

Entities

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

View source record ↗

Frequently asked questions

Has PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. had other FDA enforcement actions?: Yes. Argus HQ has recorded 199 total FDA actions tied to PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: 0 warning letters, 199 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 2025-05-14; 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 (2025). Philips Medical Systems Nederland B.V. — Class II recall: IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 8…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-medical-systems-nederland-b-v-z-1740-2025

MLA

"Philips Medical Systems Nederland B.V. — Class II recall: IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 8…." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/events/fda-recall-philips-medical-systems-nederland-b-v-z-1740-2025.

Chicago

Argus HQ Research. "Philips Medical Systems Nederland B.V. — Class II recall: IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 8…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-philips-medical-systems-nederland-b-v-z-1740-2025.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_philips_medical_systems_nederland_b_v_z_1740_2025_2025,
  title = {Philips Medical Systems Nederland B.V. — Class II recall: IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 8…},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-philips-medical-systems-nederland-b-v-z-1740-2025},
  note = {Accessed: July 17, 2026}
}

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