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Priority review Notice Added Final

Inogen Rove 6 oxygen concentrator safety notice

Favicon for ansm.sante.fr ANSM Drug & Device Safety Alerts
Published April 2nd, 2026
Detected April 2nd, 2026
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Summary

ANSM has issued safety notice R2608138 informing three French home health providers about a field safety corrective action by manufacturer Inogen Inc. regarding the Inogen Rove 6 portable oxygen concentrator. The action was conducted directly by Inogen Inc., with ANSM acting as the notification authority. Providers should consult the attached manufacturer correspondence for specific safety instructions.

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What changed

ANSM has registered safety action R2608138 concerning Inogen Inc.'s Rove 6 portable oxygen concentrator. The French regulator was informed of a field safety corrective action being implemented by the manufacturer, and has forwarded the manufacturer's letter to the three affected home health providers in France. The specific nature of the safety concern is contained in the attached correspondence dated 02/04/2026.

Home health providers using this device should review the attached manufacturer letter immediately and follow any instructions provided. Questions regarding the safety action should be directed to Inogen Inc. as the issuer. ANSM has recorded this action under reference R2608138 for tracking purposes.

What to do next

  1. Review the attached manufacturer correspondence from Inogen Inc. dated 02/04/2026
  2. Follow any safety instructions provided in the field corrective action letter
  3. Direct questions to Inogen Inc. as specified by ANSM

Source document (simplified)

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Information n° R2608138 destinée aux prestataires de santé à domicile L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Inogen Inc.
Les 3 prestataires de santé concernés en France ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2608138.
Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Consultez le courrier de la société Inogen Inc. (02/04/2026)

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Source

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ANSM Drug & Device Safety Alerts ansm.sante.fr/informations-de-securite
Pharma & Drug Safety
Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
ANSM
Published
April 2nd, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
R2608138

Who this affects

Applies to
Healthcare providers Medical device makers
Industry sector
3345 Medical Device Manufacturing 6211 Healthcare Providers
Activity scope
Medical Device Safety
Geographic scope
France FR

Taxonomy

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

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