Changeflow GovPing Pharma & Drug Safety Aerys Medical Bed Half-Rails Safety Recall by W...
Urgent Enforcement Amended Final

Aerys Medical Bed Half-Rails Safety Recall by Winncare France

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Summary

ANSM has published a safety alert regarding a field safety corrective action (FSCA No. R2610462) conducted by Winncare France for Aerys and Aerys Confort sliding medical bed half-rails. Users of the affected products have received direct correspondence from Winncare France. The alert is directed to pharmacies, community care facilities, retail establishments, and home health service providers.

What changed

ANSM has issued a safety alert (R2610462) regarding a field safety corrective action by Winncare France for Aerys and Aerys Confort sliding medical bed half-rails. The corrective action has been implemented by the manufacturer, and affected users have received direct notification from Winncare France.

Healthcare providers, pharmacies, and home health service providers should immediately verify whether they possess any affected Aerys bed half-rails, follow the corrective action procedures outlined by Winncare France, and retain documentation demonstrating compliance with the recall. Questions should be directed to Winncare France as the issuer of the safety action.

What to do next

  1. Verify if inventory includes affected Aerys or Aerys Confort sliding bed half-rails
  2. Contact Winncare France directly for corrective action procedures
  3. Retain documentation of recall compliance actions

Archived snapshot

Apr 15, 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° R2610462 destinée aux officines, structures de soins de ville, grandes et moyennes surfaces et prestataires de santé à domicile L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Winncare France.

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2610462. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Winncare France (15/04/2026)

Named provisions

FSCA R2610462

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Last updated

Classification

Agency
ANSM
Filed
April 15th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
R2610462
Docket
R2610462

Who this affects

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

Taxonomy

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

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