PV Bulletin

ANSM (France) - Safety information feed: Appareil de radiologie interventionnelle - RX – Intuis – Philips Medical Systems Nederland BV sur le site de l'Agence nationale de sécurité du médicamentet des produits de santé Information de sécurité -

Philips has identified a potential safety issue with the Intuis system that could lead to the loss of imaging functionality during clinical use.

Primary source: Téléchargez le courrier de la société Philips Medical Systems Nederland BV (04/09/2026)

Translated From Another Language

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 was issued by ANSM regarding the Philips Intuis device detailing an urgent safety issue and the need for a corrective action.

Why it matters

Failure to address the overheating issue may lead to imaging loss during procedures, which could result in procedural complications or treatment delays, impacting patient health significantly.

Action needed

Philips is implementing a corrective safety action, and users must respond within 30 days to the included response form to address this safety concern. The modified cable expected to rectify the issue will be available by January 2027.

Relevant for
QPPVSignal Management 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 4, 2026

Full briefing

Practical implication

Philips is implementing a corrective safety action, and users must respond within 30 days to the included response form to address this safety concern. The modified cable expected to rectify the issue will be available by January 2027.

A safety notification indicates that an overheating power connection in the Philips Intuis interventional radiology system may deteriorate over time, potentially causing loss of imaging functionality. Immediate corrective action is required to mitigate patient safety risks associated with this issue.

What changed: A safety notification was issued by ANSM regarding the Philips Intuis device detailing an urgent safety issue and the need for a corrective action.

Why it matters: Failure to address the overheating issue may lead to imaging loss during procedures, which could result in procedural complications or treatment delays, impacting patient health significantly.

Practical implication: Philips is implementing a corrective safety action, and users must respond within 30 days to the included response form to address this safety concern. The modified cable expected to rectify the issue will be available by January 2027.

View original source

  • Source: ANSM (France) - Safety information feed
  • Published at source: 2026-09-04T00:00:00.000Z
  • Discovered by monitor: 2026-09-04T21:36:01.374Z

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

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