PV Bulletin

Philips MRI Systems with DTI Safety Notification

Philips has informed users of potential safety issues concerning MRI systems with diffusion tensor imaging (DTI) that may pose risks to patients due to incorrect data in MR DICOM exports.

Primary source: Téléchargez le courrier de la société Philips (10/09/2026)

Translated From French

PV Bulletin does not take any responsibility for translation errors or omissions, though it has used the best available translation engine.

PV Impact Brief

Urgency: HighConfidence: high

What changed

A safety notification has been issued concerning Philips MRI systems with DTI due to identified incorrect data in MR DICOM exports, requiring healthcare facilities to review the implications and respond within 30 days.

Why it matters

Inaccurate image reconstructions can lead to inappropriate treatment plans, potentially causing serious harm or even patient death. This necessitates immediate attention to avoid adverse events.

Action needed

Affected healthcare facilities must archive the safety notification and submit responses to Philips regarding necessary safety measures within 30 days.

Relevant for
Regulatory Intelligence Lead
Processes impacted
Signal Management
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Sep 10, 2026

Full briefing

Practical implication

Affected healthcare facilities must archive the safety notification and submit responses to Philips regarding necessary safety measures within 30 days.

On September 10, 2026, the ANSM issued a safety notification regarding Philips MRI systems with DTI, highlighting incorrect data in MR DICOM exports that could lead to improper patient treatment. Users must act promptly to address the issue and ensure safe usage of the affected equipment.

What changed: A safety notification has been issued concerning Philips MRI systems with DTI due to identified incorrect data in MR DICOM exports, requiring healthcare facilities to review the implications and respond within 30 days.

Why it matters: Inaccurate image reconstructions can lead to inappropriate treatment plans, potentially causing serious harm or even patient death. This necessitates immediate attention to avoid adverse events.

Practical implication: Affected healthcare facilities must archive the safety notification and submit responses to Philips regarding necessary safety measures within 30 days.

View original source

  • Source: ANSM (France) - Safety information feed
  • Published at source: 2026-09-10T00:00:00.000Z
  • Discovered by monitor: 2026-09-10T21:31:36.026Z

Published from the regulator source ingestion pipeline after PV impact triage.

#Safety Signal#Safety Signals#Source-ingestion#Regulator-monitor#Translated From French#France#Ansm.sante.fr

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