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BfArM lists urgent field safety notice for PTW Track-it software

🇩🇪 BfArM field safety notices · Thu 12 Nov 2026

The German regulator has published a PTW Freiburg field safety notice on Track-it, a radiotherapy treatment planning product, but the specifics sit in the manufacturer's attached advisory.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice on 12 November 2026 for Track-it software made by PTW Freiburg, Physikalisch-Technische Werkstätten Dr. Pychlau GmbH.

The listing places the product in the group "Radiotherapy / Radiation protection - radiotherapy treatment planning systems" and carries the reference 50781/26. BfArM's entry does not describe the nature of the problem, the versions affected or the risk to patients.

For further information and device details, the regulator points readers to the manufacturer's Advisory Notice, attached to the listing as a PDF of about 930 KB. Any corrective actions requested of users are contained in that document rather than in the BfArM text.

As general context, a field safety notice is the communication a manufacturer sends to users when it takes a field safety corrective action for a medical device. Regulators such as BfArM publish these notices so that affected customers and the wider vigilance community can see them.

What it means for your team

  • Teams using PTW Track-it should obtain and read the manufacturer's Advisory Notice under reference 50781/26 to establish whether their installations are affected.
  • Because the BfArM listing gives no detail on the issue, impact assessment and any required actions must be based on the full notice.
  • Vigilance and quality staff at radiotherapy departments may wish to document receipt of the notice and any follow-up in line with their internal 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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