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BfArM publishes exocad field safety notice for exoplan dental implant planning software

🇩🇪 BfArM field safety notices · Fri 06 Nov 2026

Germany's BfArM has listed an Urgent Field Safety Notice from exocad GmbH covering exoplan, with the substance contained in the manufacturer's attached Advisory Notice.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice from exocad GmbH on 6 November 2026. The notice concerns exoplan, which the listing places in the product group of medical data processing software, specifically software for computer-based treatment.

The entry carries the reference number 48860/26. It does not describe the problem that prompted the notice, the software versions affected, or the actions users are expected to take. Instead, it directs readers to the manufacturer's Advisory Notice, which is attached as a PDF of about 1MB.

Because the BfArM listing is limited to this pointer, the safety issue and any corrective measures cannot be assessed from the web entry alone. Field safety notices are issued by manufacturers to inform users of a safety-related problem with a marketed device and, where relevant, to set out corrective steps. Regulators such as BfArM make them publicly available.

What it means for your team

  • Organisations that use or distribute exoplan should obtain and read the full Advisory Notice from exocad GmbH to find out whether they are affected.
  • Quality and regulatory teams can use reference 48860/26 to log the notice and track it within their field safety corrective action processes.
  • The BfArM listing gives no details on the issue, affected versions or user actions, so no conclusions should be drawn until the manufacturer's document has been reviewed.

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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