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BfArM lists Philips urgent field safety notice for Azurion image-guided therapy system

🇩🇪 BfArM field safety notices · Fri 30 Oct 2026

Germany's medicines and devices authority has published a Philips Medical Systems Nederland field safety notice for Azurion, but the nature of the issue sits only in the manufacturer's attached advisory.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice on 30 October 2026 from Philips Medical Systems Nederland B.V. relating to its Azurion device. The entry is filed under BfArM reference 48623/26.

BfArM classes the product group as radiological technology, specifically radiological equipment for vascular diagnostics. The listing describes Azurion in those terms and does not go further on the device's intended use.

The public listing contains no details of the problem, the affected models or serial numbers, or the actions users are asked to take. BfArM directs readers to the manufacturer's Advisory Notice, attached as a 407 KB PDF. The authority flags that the file does not meet accessibility standards.

As general context, a field safety notice is the communication a manufacturer sends to customers when it takes a field safety corrective action on a marketed medical device. Competent authorities such as BfArM publish these notices so that users and vigilance staff can assess whether their equipment is affected.

What it means for your team

  • Download and read the full Philips Advisory Notice; the BfArM listing does not state the issue, scope or required actions.
  • Hospital and imaging-department QA and vigilance teams should check their installed Azurion units against the notice's affected-product details and record the outcome.
  • Cross-reference BfArM reference 48623/26 in internal field-action logs and follow any response steps the manufacturer specifies.
  • Manufacturers' regulatory teams and distributors should confirm they hold the notice, as the public text gives no further detail.

Official source: BfArM field safety notices ↗

Article written by VigiEye from the official source (BfArM field safety notices). AI-assisted; check the source before acting.

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