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fda_recall · device_recall · high

Philips Medical Systems Technologies Ltd. — Class II recall: Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software…

Event date
2024-11-27 00:00:00Z
Observed
2026-07-16 23:20:11Z
Source ID
Z-0497-2025
Payload hash
a7610cf377de900366a0da33

Summary

A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calculations when using the export function in the Perfusion Application for a Siemens CT perfusion study, resulting in misdiagnosis due to incorrect ischemic map and table values. Status: Ongoing.

Frequently asked questions

Has Philips Medical Systems Technologies Ltd. had other FDA enforcement actions?
This is the only FDA action Argus HQ has on file for Philips Medical Systems Technologies Ltd. as of 2026-07-16. Argus ingests new FDA enforcement records daily.
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 2024-11-27; 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 Medical Systems Technologies Ltd. — Class II recall: Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-philips-medical-systems-technologies-ltd-z-0497-2025
MLA
"Philips Medical Systems Technologies Ltd. — Class II recall: Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software…." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/events/fda-recall-philips-medical-systems-technologies-ltd-z-0497-2025.
Chicago
Argus HQ Research. "Philips Medical Systems Technologies Ltd. — Class II recall: Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-philips-medical-systems-technologies-ltd-z-0497-2025.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_philips_medical_systems_technologies_ltd_z_0497_2025_2024,
  title = {Philips Medical Systems Technologies Ltd. — Class II recall: Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-philips-medical-systems-technologies-ltd-z-0497-2025},
  note = {Accessed: July 17, 2026}
}

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