Changeflow GovPing Pharma & Drug Safety Vue PACS v12 Philips Medical Systems Safety Recall
Urgent Enforcement Added Final

Vue PACS v12 Philips Medical Systems Safety Recall

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Filed April 3rd, 2026
Detected April 3rd, 2026
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Summary

ANSM reported a safety action by Philips Medical Systems Nederland BV regarding Vue PACS v12. Users have received direct notification from the manufacturer. The safety action is registered under reference R2607071.

What changed

ANSM has recorded a safety action (Ref. R2607071) initiated by Philips Medical Systems Nederland BV for Vue PACS v12 software used in medical imaging services. Users of the affected system have been directly notified by Philips and received a safety letter dated 03/04/2026.

Healthcare providers using Vue PACS v12 should immediately review and act upon the safety instructions received from Philips Medical Systems. Contact the manufacturer directly with any questions regarding the corrective measures required.

What to do next

  1. Review the safety letter received from Philips Medical Systems
  2. Follow all corrective measures specified in the manufacturer's communication
  3. Contact Philips directly for any questions about required actions

Source document (simplified)

A+ A-

Information n° R2607071 destinée aux services d'imagerie L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Philips Medical Systems Nederland BV.

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2607071. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Philips Medical Systems Nederland BV (03/04/2026)

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
ANSM
Filed
April 3rd, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Minor
Document ID
R2607071

Who this affects

Applies to
Healthcare providers Medical device makers
Industry sector
3345 Medical Device Manufacturing 6211 Healthcare Providers
Activity scope
Medical Device Safety Notification
Threshold
Users of Vue PACS v12
Geographic scope
France FR

Taxonomy

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

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