GE Healthcare Signa Premier MRI Safety Notice

ANSM Drug & Device Safety Alerts

Published March 31st, 2026

Detected March 31st, 2026

Summary

ANSM informed health facilities and medical imaging centers of a safety action by GE Healthcare regarding the Signa Premier MRI system. The action is registered under reference R2608457. Healthcare providers who received the letter should review and implement the specified safety measures.

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What changed

ANSM issued a safety notice (R2608457) regarding GE Healthcare's Signa Premier MRI system. This field safety action was implemented by GE Healthcare and notified to the French regulatory authority. Healthcare facilities and medical imaging centers using this MRI equipment have received a direct communication from GE Healthcare outlining the specific safety measures.

Affected healthcare providers must immediately review the attached GE Healthcare letter (dated 31/03/2026) and implement any required safety actions. Medical device users should not delay in accessing the field safety notice to ensure patient safety during MRI procedures. Questions should be directed to GE Healthcare as the originator of the safety action.

What to do next

Review the attached GE Healthcare field safety notice for the Signa Premier MRI
Implement any safety measures or recommendations specified in the manufacturer's communication
Direct questions about the safety action to GE Healthcare directly

Source document (simplified)

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Information n° R2608457 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 GE Healthcare.
Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2608457.
Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Consultez le courrier de la société GE Healthcare (31/03/2026)