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Urgent Enforcement Amended Final

Elekta Cervical/Intrauterine Brachytherapy System Safety Recall

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Summary

ANSM published safety alert R2610148 informing healthcare facilities of a medical device safety action by Elekta regarding its cervical/intrauterine brachytherapy system. Users of affected devices have received direct notification from Elekta. The recall is effective April 9, 2026, and healthcare providers using this radiation therapy equipment must take immediate action.

What changed

ANSM has published a safety alert documenting Elekta's recall of cervical/intrauterine brachytherapy systems under reference R2610148. The agency confirms that affected users have received direct notification from Elekta with details of the safety action. This follows Elekta's implementation of a corrective measure for the radiation therapy device.

Healthcare facilities using Elekta brachytherapy equipment must review the manufacturer correspondence to identify affected units and implement required corrective actions. Radiation oncology departments and clinical engineering teams should cross-reference serial numbers and take immediate steps to comply with Elekta's instructions to avoid patient treatment risks.

What to do next

  1. Identify whether your facility uses Elekta cervical/intrauterine brachytherapy systems
  2. Review the Elekta safety letter (dated 09/04/2026) for specific affected model numbers
  3. Implement any customer-reported corrective actions or follow Elekta's instructions immediately

Archived snapshot

Apr 9, 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° R2610148 destinée aux établissements de santé L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Elekta.

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2610148. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Elekta (09/04/2026)

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Last updated

Classification

Agency
ANSM
Filed
April 9th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
R2610148

Who this affects

Applies to
Medical device makers Healthcare providers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical device recall Radiation therapy equipment Patient safety response
Geographic scope
France FR

Taxonomy

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

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