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BfArM publishes Olympus field safety notice for HF and Versapoint connector cables

🇩🇪 BfArM field safety notices · Mon 26 Oct 2026

Germany's regulator has posted an Urgent Field Safety Notice from Olympus Winter & Ibe GmbH covering four electrosurgical cable products, with details held in the manufacturer's attached notice.

The Federal Institute for Drugs and Medical Devices (BfArM) has published an Urgent Field Safety Notice from Olympus Winter & Ibe GmbH. It covers the HF-cable monopolar, the HF-cable HiQ+ bipolar, the HF-cable and the Versapoint Connector Cable.

BfArM lists the notice under reference 48638/26 and dated 26 October 2026. It places the products in the product group medical electronics, specifically electromedical devices for electrotherapy.

The BfArM web entry does not describe the problem behind the notice, the affected models or batches, or the actions users are asked to take. It refers readers to the manufacturer's Advisory Notice, which is attached as an 830 KB PDF.

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 marketed medical device. Regulators such as BfArM publish these notices so that healthcare facilities and other stakeholders can see them.

What it means for your team

  • Read the full Olympus Advisory Notice, since the BfArM page gives no information on the issue, scope or required actions.
  • Check whether any of the four named cable products are in use or in stock at your sites, and identify who is responsible for acting on the notice.
  • Quality and vigilance teams should log the notice under BfArM reference 48638/26 and track any follow-up the manufacturer requests.

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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