PharmacovigilanceOfficial

Brainlab warns of surface-matching registration problems in neonates and infants using Cranial EM navigation software

🇳🇱 IGJ · Sun 08 Nov 2026

A Brainlab field safety notice, published by Dutch inspectorate IGJ, says registration may fail or give unusable results in under-twos when Cranial EM is used with Universal Atlas 6.0.

Brainlab SE has issued a field safety notice (FSN) about its Navigation Software Cranial EM, according to a warning published by the Dutch healthcare inspectorate IGJ. The manufacturer's notice is dated 22 October 2026, and the IGJ page carrying the warning is dated 9 November 2026.

The issue concerns use of the software together with the Universal Atlas 6.0 software submodule in neonates, defined as younger than 29 days, and in infants, aged 29 days to under 2 years. In these patients, Surface Matching registration for navigation may not be possible or may produce unusable results, Brainlab says.

The source text does not describe any patient harm, the number of affected units or sites, or the specific corrective actions requested of users. Those details are likely to sit in the two-page PDF notice linked from the IGJ page, which was not available for this report.

The IGJ notes that the warning comes from the manufacturer. Under the EU framework, manufacturers must monitor devices after they reach the market and act where a risk to users arises, informing users and the inspectorate through a field safety notice.

What it means for your team

  • Hospitals using Cranial EM with Universal Atlas 6.0 in paediatric neurosurgery should obtain and read the full FSN to confirm the scope and any required actions.
  • Vigilance and quality teams should check whether the affected age groups, neonates and infants under two, are treated at their sites, and log receipt of the notice.
  • Manufacturers and authorised representatives should note that the specific hazard and corrective actions are not given in the IGJ summary, so the full FSN is the primary reference.

Official source: IGJ ↗

Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.

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