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Urgent Enforcement Amended Final

Monnal TEO Ventilator Field Safety Corrective Action - Air Liquide Medical Systems

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Summary

ANSM published a safety notice regarding field safety corrective action R2531145 for Air Liquide Medical Systems' Monnal TEO ventilator. The manufacturer issued updated safety correspondence dated 10 April 2026 superseding the November 2025 notification. Healthcare establishments using this resuscitation ventilator must review the corrective action requirements directly from the manufacturer.

What changed

ANSM documented a field safety corrective action by Air Liquide Medical Systems for the Monnal TEO ventilator under reference R2531145. The original safety notice was issued November 19, 2025, with an updated communication released April 10, 2026. The manufacturer initiated this action following identification of a safety concern requiring corrective measures.

Healthcare establishments using Monnal TEO ventilators must obtain and review both manufacturer correspondence documents. Clinical engineering and biomedical departments should coordinate implementation of required corrective actions and maintain documentation of compliance. The ANSM registration number R2531145 should be referenced for any inquiries directly to Air Liquide Medical Systems.

What to do next

  1. Identify all Monnal TEO ventilators in your facility
  2. Review Air Liquide Medical Systems safety correspondence dated April 2025 and November 2025
  3. Implement any required corrective actions specified in the manufacturer's field safety notice

Archived snapshot

Apr 10, 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.

A+ A-

Information n° R2531145 destinée aux établissements de santé L'ANSM a été informée de la mise à jour d’une action de sécurité effectuée par la société Air Liquide Medical Systems.

Les utilisateurs déjà concernés par le précédent courrier ont reçu le nouveau courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2531145. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Air Liquide Medical Systems (10/04/2026)

Information du 19/11/2025

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2531145. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité.

L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Air Liquide Medical Systems.

Les utilisateurs concernés ont reçu le courrier ci-joint. Téléchargez le courrier de la société Air Liquide Medical Systems de novembre 2025 (19/11/2025)

Named provisions

Monnal TEO Ventilator Safety Notice

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Last updated

Classification

Agency
ANSM
Filed
April 10th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
R2531145
Supersedes
R2531145 (November 2025)

Who this affects

Applies to
Healthcare providers Medical device makers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical device safety monitoring Field safety corrective action Ventilator maintenance
Geographic scope
France FR

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Healthcare Public Health

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