Has Philips North America had other FDA enforcement actions?

Yes. Argus HQ has recorded 369 total FDA actions tied to Philips North America: 0 warning letters, 369 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 2026-10-07; Argus observed and indexed it on 2026-10-13.

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 — Class II recall: SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Vers…

Name: FDA Recall Record — Philips North America
Creator: Argus HQ
Published: 2026-10-07
License: https://argushq.ai/methodology

Event date: 2026-10-07 00:00:00Z
Observed: 2026-10-13 04:20:35Z
Source ID: Z-3315-2026
Payload hash: edfd1bea0aedf4484c754a76…

Summary

When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathway… 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 369 total FDA actions tied to Philips North America: 0 warning letters, 369 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 2026-10-07; Argus observed and indexed it on 2026-10-13.
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 (2026). Philips North America — Class II recall: SmartPath to MR 7700;  Model number (REF): 1. 782178, 2. 782207;   Software Vers…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-north-america-z-3315-2026

MLA

"Philips North America — Class II recall: SmartPath to MR 7700;  Model number (REF): 1. 782178, 2. 782207;   Software Vers…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-philips-north-america-z-3315-2026.

Chicago

Argus HQ Research. "Philips North America — Class II recall: SmartPath to MR 7700;  Model number (REF): 1. 782178, 2. 782207;   Software Vers…." Digital Empire Holdings LLC. Accessed October 13, 2026. https://argushq.ai/events/fda-recall-philips-north-america-z-3315-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_philips_north_america_z_3315_2026_2026,
  title = {Philips North America — Class II recall: SmartPath to MR 7700;  Model number (REF): 1. 782178, 2. 782207;   Software Vers…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-philips-north-america-z-3315-2026},
  note = {Accessed: October 13, 2026}
}

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