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BfArM publishes Getinge Disinfection field safety notice for CM320-series washer-disinfectors

🇩🇪 BfArM field safety notices · Wed 28 Oct 2026

Germany's federal medicines and devices authority has listed an urgent field safety notice from Getinge Disinfection AB, but the details sit in the manufacturer's attached advisory document.

The German Federal Institute for Drugs and Medical Devices (BfArM) has posted an Urgent Field Safety Notice from Getinge Disinfection AB relating to the CM320-series. The entry is dated 28 October 2026 and carries the reference 29788/25.

BfArM classes the product under general equipment for medical treatment, in the sub-area of cleaning, disinfection and sterilisation. The CM320-series is a range of washer-disinfectors, according to the information on file.

The BfArM listing itself is brief. It does not describe the hazard, identify affected units or serial numbers, or set out any actions for users. It simply directs readers to the manufacturer's enclosed Advisory Notice for further information and device details. That notice is attached as a 321 KB PDF.

Field safety notices are the formal means by which manufacturers inform users of a safety-related corrective action for a medical device on the market. National authorities such as BfArM publish them so that healthcare facilities and other stakeholders can access them.

What it means for your team

  • Facilities that use Getinge CM320-series equipment should obtain and read the full Advisory Notice from the BfArM page or from Getinge, as the BfArM text gives no hazard or action details.
  • Quality and reprocessing teams should check their installed base against the notice's scope once they have the document, since the listing does not specify affected units.
  • Regulatory and vigilance staff should log reference 29788/25 and the 28 October 2026 publication date in their field safety corrective action tracking.

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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