Has Philips North America had other FDA enforcement actions?

Yes. Argus HQ has recorded 355 total FDA actions tied to Philips North America: 0 warning letters, 355 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 2024-10-16; 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 North America Llc — Class II recall: IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01…

Name: FDA Recall Record — Philips North America
Creator: Argus HQ
Published: 2024-10-16
License: https://argushq.ai/methodology

Event date: 2024-10-16 00:00:00Z
Observed: 2026-07-16 23:20:11Z
Source ID: Z-0020-2025
Payload hash: 42c966e0d5a90fbdc619923e…

Summary

Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices. Without Option C01 Full Arrhythmia, the device will not provide the yellow alarms f… Status: Ongoing.

Entities

Philips North America

View source record ↗

Frequently asked questions

Has Philips North America had other FDA enforcement actions?: Yes. Argus HQ has recorded 355 total FDA actions tied to Philips North America: 0 warning letters, 355 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 2024-10-16; 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 (2024). Philips North America Llc — Class II recall: IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-north-america-llc-z-0020-2025

MLA

"Philips North America Llc — Class II recall: IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01…." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/events/fda-recall-philips-north-america-llc-z-0020-2025.

Chicago

Argus HQ Research. "Philips North America Llc — Class II recall: IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-philips-north-america-llc-z-0020-2025.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_philips_north_america_llc_z_0020_2025_2024,
  title = {Philips North America Llc — Class II recall: IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-philips-north-america-llc-z-0020-2025},
  note = {Accessed: July 17, 2026}
}

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