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Da Vinci X Xi Cannula Screw Safety Notice - Intuitive Surgical

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Summary

ANSM has published a safety notice (Reference R2606328) informing French healthcare facilities about a safety action by Intuitive Surgical regarding cannula support screws on da Vinci X and Xi robotic surgical systems. Users have received direct communication from the manufacturer. Healthcare facilities with these systems should review the attached manufacturer letter for specific guidance.

Published by ANSM on ansm.sante.fr . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

What changed

ANSM has published a safety notice informing healthcare facilities about a safety action performed by Intuitive Surgical regarding cannula support screws on da Vinci X and Xi robotic surgical systems. The safety action is registered under reference number R2606328. Affected healthcare providers using these surgical systems should review the manufacturer communication directly and contact Intuitive Surgical for further information.

Healthcare facilities with da Vinci X or Xi systems should monitor for the attached manufacturer communication and take appropriate follow-up actions as directed by Intuitive Surgical. ANSM has made the manufacturer letter available for download and advises users to address questions to the manufacturer directly.

What to do next

  1. Review manufacturer communication from Intuitive Surgical
  2. Contact Intuitive Surgical for questions regarding this safety action
  3. Assess da Vinci X and Xi systems for the cannula screw issue

Archived snapshot

Apr 13, 2026

GovPing 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.

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Information n° R2606328 destinée aux pharmacies d'usage intérieur et établissements de santé L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Intuitive Surgical.

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2606328. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Intuitive Surgical (13/04/2026)

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Last updated

Classification

Agency
ANSM
Published
April 13th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Substantive
Document ID
R2606328

Who this affects

Applies to
Medical device makers Healthcare providers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical device safety monitoring Surgical system maintenance
Geographic scope
France FR

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Healthcare Product Safety

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