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.

