Resoundant Acoustic Transducer for MRI - Safety Action

ANSM Drug & Device Safety Alerts

Published March 26th, 2026

Detected March 26th, 2026

Summary

The French National Agency for Medicines and Health Products Safety (ANSM) has registered a safety action concerning the Resoundant acoustic transducer for MRI, identified under number R2606244. Healthcare facilities and medical imaging centers using this device have been notified.

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What changed

The ANSM has recorded a safety action, designated R2606244, initiated by the company Resoundant regarding its acoustic transducer for magnetic resonance elastography. This action is specifically directed at healthcare facilities and medical imaging centers that utilize this device. The ANSM has been informed of the implementation of this safety measure, and affected users have received a direct communication from Resoundant, including a letter dated March 26, 2026.

Healthcare providers using the Resoundant acoustic transducer for MRI should review the safety communication and the attached letter from Resoundant for specific instructions and guidance. For any inquiries regarding this safety action, direct contact with Resoundant, the issuer of the action, is recommended. The ANSM's role here is to record and acknowledge the safety measure being implemented by the manufacturer.

What to do next

Review the safety information and Resoundant's communication regarding the acoustic transducer.
Contact Resoundant directly for any questions or specific guidance related to the safety action.

Source document (simplified)

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Information n° R2606244 destinée aux établissements de santé, centres d’imagerie médicale L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Resoundant.
Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2606244.
Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Consultez le courrier de la société Resoundant (26/03/2026)