Philips Azurion Interventional Radiology Recall, 847 Units
Summary
ANSM has recorded safety action R2603230 regarding Philips Azurion interventional radiology systems manufactured by Philips Medical Systems Nederland BV. Affected French healthcare facilities have received direct notification from Philips. The recall encompasses 847 units of the Azurion system. Healthcare providers should immediately review their inventory and contact Philips Medical Systems for corrective action.
What changed
ANSM has recorded safety action R2603230 relating to Philips Azurion interventional radiology equipment following a manufacturer-initiated field safety corrective action. Philips Medical Systems Nederland BV has notified affected French healthcare facilities of the recall via correspondence dated 08/04/2026. The action affects 847 units of the Azurion system deployed across France.
Healthcare facilities utilizing Philips Azurion systems must review their device inventory against the recall parameters, implement any interim mitigation measures specified by Philips, and coordinate directly with the manufacturer for corrective action. Facility compliance officers should ensure clinical engineering teams are briefed, patient scheduling impacts are assessed, and all communications with ANSM and Philips are documented. Device inventory records must be updated to reflect the recall status.
What to do next
- Identify all Philips Azurion systems in your facility matching the recall scope
- Contact Philips Medical Systems Nederland BV directly for corrective action instructions
- Report any adverse events or device malfunctions to ANSM
Archived snapshot
Apr 8, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Information n° R2603230 destinée aux services d'imagerie L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Philips Medical Systems Nederland BV.
Les utilisateurs concernés ont reçu le courrier ci-joint.
Cette action de sécurité est enregistrée à l’ANSM sous le n° R2603230. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Philips Medical Systems Nederland BV (08/04/2026)
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