PharmacovigilanceOfficial

Löwenstein Medical issues field safety notice for LEONI 4 touchscreen fault

🇳🇱 IGJ · Thu 12 Nov 2026

The Dutch inspectorate has published a manufacturer warning saying unintended touch signals at the LEONI 4 screen edge can temporarily limit or fully block touchscreen operation.

The Dutch Health and Youth Care Inspectorate (IGJ) has published a manufacturer warning about the LEONI 4, a medical device made by Löwenstein Medical Netherlands B.V. The notice describes a touchscreen problem.

According to the notice, unintended touch signals can in some cases occur at the edge of the screen. This can temporarily restrict operation via the touchscreen or block it completely.

The manufacturer's Field Safety Notice (FSN) is dated 10 November 2026. IGJ makes it available as a six-page PDF. The published text does not list corrective actions, affected batches or serial numbers, and does not describe clinical consequences.

IGJ presents the item as a warning from the manufacturer, not as an inspectorate measure. It notes that manufacturers must monitor devices after they reach the market and improve them where necessary. Where a risk to users exists, they must act and inform both users and the inspection through an FSN.

What it means for your team

  • Vigilance and quality teams at organisations that use or distribute the LEONI 4 should obtain the full FSN PDF, as the IGJ page gives no details on scope or actions.
  • Because the notice does not state affected batches or required actions, confirm these directly with the manufacturer before assessing impact.
  • Operational teams may want to check whether any loss of touchscreen control has already been reported internally, and whether such events were logged as incidents.

Official source: IGJ ↗

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

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