Changeflow GovPing Pharma & Drug Safety Philips Spectral CT Scanner Software Safety Alert
Priority review Notice Amended Final

Philips Spectral CT Scanner Software Safety Alert

Favicon for ansm.sante.fr ANSM Drug & Device Safety Alerts
Published March 17th, 2026
Detected March 17th, 2026
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Summary

The French ANSM has issued a safety alert (R2607608) regarding Philips Spectral CT scanner systems with software version 5.1.X. Healthcare facilities using these devices have been notified of a security action initiated by Philips Medical Systems BV.

What changed

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert (R2607608) concerning Philips Spectral CT scanner systems utilizing software version 5.1.X. This alert informs healthcare facilities and medical imaging centers about a security action being implemented by Philips Medical Systems BV. The specific details of the security action and the affected devices are outlined in a letter from Philips, dated March 17, 2026.

Healthcare providers using the affected Philips Spectral CT scanners must review the provided correspondence from Philips Medical Systems BV for detailed instructions on the security action. While this is a safety alert and not a direct regulatory mandate from ANSM, compliance with the manufacturer's recommended security measures is crucial to ensure patient safety and device integrity. No specific compliance deadline or penalty information is provided in this notice, but prompt attention to the manufacturer's guidance is advised.

What to do next

  1. Review Philips Medical Systems BV's security action letter dated 2026-03-17.
  2. Implement recommended security measures for Philips Spectral CT scanner systems with software version 5.1.X.

Source document (simplified)

A+ A-

Information n° R2607608 destinée aux établissements de santé, centres d’imagerie médicale L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Philips Medical Systems BV.
Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2607608.
Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Consultez le courrier de la société Philips Medical Systems BV (17/03/2026)

Source

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

Classification

Agency
ANSM
Published
March 17th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Healthcare providers
Geographic scope
France

Taxonomy

Primary area
Healthcare
Operational domain
Compliance
Topics
Medical Devices Product Safety

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