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BfArM publishes Gyrus ACMI urgent field safety notice for SOLTIVE single-use laser fibers

🇩🇪 BfArM field safety notices · Thu 22 Oct 2026

Germany's regulator has posted a manufacturer safety notice for SOLTIVE laser fibers, but the defect, affected lots and required actions appear only in the attached advisory.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice on 22 October 2026 from Gyrus ACMI Inc. covering SOLTIVE single-use laser fibers. The notice is filed under reference 43069/26 and classed in the product group Optics / Precision engineering - laser technology.

The BfArM listing contains no description of the problem. It does not name the defect, identify affected lots or serial numbers, or set out what users should do. It refers readers to the manufacturer's Advisory Notice, which is attached as a 762KB PDF.

As a result, the scale and nature of the issue cannot be assessed from the BfArM page alone. Anyone relying on the listing should obtain the full advisory before drawing conclusions about risk or scope.

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 marketed device. National authorities such as BfArM make these notices publicly available.

What it means for your team

  • Quality and vigilance teams should download and read the Gyrus ACMI Advisory Notice (reference 43069/26) to establish the defect, affected lots and required actions.
  • Hospitals and device users should check whether SOLTIVE single-use laser fibers are in their inventory and compare any stock against the details in the advisory.
  • Teams should record receipt of the notice and any follow-up actions in line with their internal field safety corrective action 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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