Primary source: Téléchargez le courrier de la société Philips Medical Systems Nederland BV (04/09/2026)
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A safety notification was issued by ANSM regarding the Philips Intuis device detailing an urgent safety issue and the need for a corrective action.
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.
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.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
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.
Published from the regulator source ingestion pipeline after PV impact triage.
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