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BfArM lists urgent field safety notice for Philips IntelliVue Patient Monitor

🇩🇪 BfArM field safety notices · Fri 13 Nov 2026

Germany's medicines and devices regulator has published a manufacturer notice on the IntelliVue Patient Monitor, but the public listing does not describe the problem or the corrective action.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice on 13 November 2026 for the IntelliVue Patient Monitor. The manufacturer named in the listing is Philips Medizin Systeme Böblingen GmbH.

The entry is filed under reference 40497/26 and classed in the product group Medical electronics / Electromedical devices - electrodiagnostics. The BfArM page does not set out the nature of the issue, the affected models or software versions, or the actions users are asked to take.

Instead, the regulator directs readers to the manufacturer's Advisory Notice, which is attached to the listing as a 410 KB PDF. Anyone wanting to know whether their devices are affected, and what to do about it, will need to read that document.

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 medical device already on the market. Regulators such as BfArM publish these notices so that users and other stakeholders can access them.

What it means for your team

  • Hospital biomedical engineering and clinical teams using IntelliVue monitors should obtain and read the Advisory Notice attached to reference 40497/26.
  • Quality and vigilance teams cannot assess risk or scope from the BfArM listing alone; the details sit only in the manufacturer's document.
  • Regulatory affairs staff tracking Philips devices should log the notice and check whether it triggers internal complaint, traceability or reporting procedures.

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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