Changeflow GovPing Pharma & Drug Safety Orbis Medication 3.x Safety Notice - DH Healthcare
Routine Guidance Added Final

Orbis Medication 3.x Safety Notice - DH Healthcare

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Published March 31st, 2026
Detected March 31st, 2026
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Summary

ANSM informed healthcare facilities of a safety action (n° R2607882) implemented by DH Healthcare GmbH regarding Orbis Medication 3.x, a computer-aided prescribing software. Users have received direct correspondence from the manufacturer. Healthcare providers using this software should review the attached safety communication.

What changed

ANSM has recorded a safety action by DH Healthcare GmbH concerning Orbis Medication 3.x, a prescription assistance software (LAP). The safety action is registered under reference number R2607882. The manufacturer distributed a letter dated March 31, 2026, to affected users informing them of the safety measures taken.

Healthcare facilities and professionals using Orbis Medication 3.x should consult the attached manufacturer correspondence for specific safety action details. Direct inquiries should be directed to DH Healthcare GmbH. No specific compliance deadline or penalties are stated in this notice.

What to do next

  1. Review the DH Healthcare GmbH safety communication regarding Orbis Medication 3.x
  2. Direct questions about the safety action to DH Healthcare GmbH
  3. Assess if Orbis Medication 3.x is in use at your facility and take appropriate follow-up actions

Source document (simplified)

A+ A-

Information n° R2607882 destinée aux services de soins, pharmacies d'usage intérieur L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société DH Healthcare Gmbh.
Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2607882.
Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Consultez le courrier de la société DH Healthcare Gmbh (31/03/2026)

Named provisions

Logiciel d'Aide à la Prescription Orbis Medication 3.x

Source

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

Classification

Agency
ANSM
Published
March 31st, 2026
Instrument
Guidance
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
R2607882

Who this affects

Applies to
Healthcare providers Medical device makers
Industry sector
3345 Medical Device Manufacturing 6211 Healthcare Providers
Activity scope
Medical Device Software Prescription Assistance Systems
Geographic scope
France FR

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Compliance frameworks
FDA 21 CFR Part 11 GxP
Topics
Medical Devices Pharmaceuticals

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