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BfArM publishes Brainlab urgent field safety notice for Navigation Software Cranial EM

🇩🇪 BfArM field safety notices · Wed 04 Nov 2026

Germany's BfArM has posted a Brainlab AG field safety notice for its cranial electromagnetic navigation software, but the listing does not describe the issue or required actions.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice on 4 November 2026 concerning Navigation Software Cranial EM, made by Brainlab AG. The item is filed under reference 51215/26.

BfArM classes the product in the group 'Surgical equipment/Anaesthesia - surgical equipment'. The listing directs readers to the manufacturer's Advisory Notice for further information and details about the device. That notice is attached as a PDF of 127 KB.

The BfArM page text does not say what problem prompted the notice, which software versions are affected, what risk has been identified, or what actions users are asked to take. Those details are presumably in the Advisory Notice, which this report has not reviewed.

As general context, a field safety notice is the communication a manufacturer sends to users of a medical device when it takes a field safety corrective action, and national competent authorities such as BfArM make such notices publicly available.

What it means for your team

  • Hospitals and neurosurgical centres using Brainlab Navigation Software Cranial EM should obtain and read the full Advisory Notice to establish whether their installations are affected.
  • Quality and vigilance teams should log reference 51215/26 and check whether the manufacturer's notice has already reached them directly.
  • Any required actions, timelines or affected versions should be taken only from the manufacturer's Advisory Notice, as the BfArM listing does not specify them.

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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