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BfArM publishes urgent field safety notice for DH Healthcare's ORBIS Medication software

🇩🇪 BfArM field safety notices · Thu 12 Nov 2026

The German regulator has listed an urgent field safety notice from DH Healthcare GmbH for ORBIS Medication, but the public listing gives no details of the problem or required actions.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an urgent field safety notice on 12 November 2026 from DH Healthcare GmbH covering its ORBIS Medication product. The entry is filed under reference 49578/26.

BfArM classes the product in the group "Medical data processing (software) - others". The listing itself contains no description of the issue, the software versions affected or the measures users are asked to take.

Instead, the regulator directs readers to the manufacturer's Advisory Notice, attached to the entry as a PDF of 546KB. That document holds the device-specific information, and its contents are not reproduced in the BfArM listing.

As general context, a field safety notice is the communication a manufacturer sends to users when it takes a field safety corrective action to reduce a risk linked to a medical device already on the market.

What it means for your team

  • Organisations using ORBIS Medication should obtain and read the manufacturer's Advisory Notice from the BfArM entry (reference 49578/26) to establish whether they are affected.
  • Quality and risk teams should check the notice for any required actions and the deadlines for them, since the BfArM listing does not specify these.
  • Vigilance and regulatory staff should log receipt of the notice and record the response 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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