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BfArM lists urgent field safety notice for Fresenius 6008 CAREsystem dialysis device

🇩🇪 BfArM field safety notices · Tue 27 Oct 2026

The German regulator has published a manufacturer safety notice for the 6008 CAREsystem, but the listing itself does not describe the hazard or the corrective actions.

The German Federal Institute for Drugs and Medical Devices (BfArM) has published an Urgent Field Safety Notice from Fresenius Medical Care AG & Co. KGaA covering the 6008 CAREsystem. The entry is dated 27 October 2026 and carries the reference 49772/26.

BfArM files the item under injections, infusions, transfusions and dialysis, specifically dialysis technology. The 6008 CAREsystem is described in the listing only by name and product group; the page does not say which units or software or hardware versions are affected.

The listing does not set out the nature of the problem, any patient-safety consequences or the actions users are asked to take. It refers readers to the manufacturer's Advisory Notice, which is attached as a 339 KB PDF. BfArM flags that the file does not meet accessibility standards.

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 device users and vigilance contacts can find them.

What it means for your team

  • Dialysis providers and technical staff using the 6008 CAREsystem should obtain and read the manufacturer's Advisory Notice, as the BfArM listing contains no detail on the issue or required actions.
  • Quality and vigilance teams should check whether the notice has reached the right internal contacts and whether any response or acknowledgement is requested in the document.
  • Regulatory teams tracking field safety corrective actions can log reference 49772/26, but should not assess scope or severity until they have reviewed the manufacturer's notice.

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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