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BfArM publishes Hologic urgent field safety notice for Horizon DXA System

🇩🇪 BfArM field safety notices · Wed 04 Nov 2026

Germany's BfArM has posted a manufacturer field safety notice for Hologic's Horizon DXA bone densitometry system, but the nature of the problem is only in the attached Advisory Notice.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice on 4 November 2026 relating to the Horizon DXA System made by Hologic, Inc., based in Danbury. The entry is filed under the product group "Radiological technology - stationary radiological equipment" and carries the reference number 49038/26.

The BfArM web entry does not describe the underlying issue, the affected models or serial numbers, or the actions users are asked to take. It states only that further information and device details are in the manufacturer's Advisory Notice, which is attached as a 2MB PDF.

The text of that Advisory Notice was not part of the material reviewed for this report, so the nature of the problem, its risk to patients or operators, and any corrective measures cannot be reported here. As general context, field safety notices are issued by manufacturers to inform users of safety-related actions concerning a marketed device, and national authorities such as BfArM make them publicly available.

What it means for your team

  • Facilities operating Hologic Horizon DXA systems in Germany should obtain and read the full Advisory Notice via BfArM reference 49038/26 to establish whether their units are affected.
  • Quality and vigilance teams should log the notice and confirm that any actions required by the manufacturer are assigned, completed and documented.
  • Details of the issue and scope are not available from the BfArM summary alone, 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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