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BfArM publishes urgent field safety notice for Löwenstein Medical's LEONI 4 device

🇩🇪 BfArM field safety notices · Fri 13 Nov 2026

Germany's BfArM has listed an urgent field safety notice from Löwenstein Medical for the LEONI 4, with hazard and corrective actions detailed only in the manufacturer's Advisory Notice.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice on 13 November 2026 concerning the LEONI 4, made by Löwenstein Medical GmbH & Co. KG. The entry is filed under reference 52289/26.

BfArM classifies the item in the product group "Surgical equipment/Anaesthesia - anaesthesia and medical gas supply". The listing itself gives no description of the problem, the affected units or the actions the manufacturer is asking users to take.

Instead, the agency directs readers to the manufacturer's Advisory Notice, which is attached to the entry as a 208 KB PDF. That document was not part of the information available for this report, so the nature of the hazard and the scope of the corrective action cannot be confirmed here.

As general context, a field safety notice is the communication a manufacturer sends to users when it takes a field safety corrective action on a medical device already on the market. Competent authorities such as BfArM publish these notices for public reference.

What it means for your team

  • Facilities and distributors holding or supplying the LEONI 4 should obtain and read the full Advisory Notice from the BfArM listing (reference 52289/26) promptly.
  • Quality and vigilance teams should establish from the notice whether specific units, batches or software versions are affected and what actions are required.
  • Until the Advisory Notice has been reviewed, no conclusions can be drawn about the risk, the affected population or deadlines for action.

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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