Quality & complianceOfficial

BfArM publishes field safety notice for FIM Medical's Audiolyser ADL Connect

🇩🇪 BfArM field safety notices · Thu 29 Oct 2026

Germany's regulator has posted a manufacturer notice on the ENT device but its own entry gives no detail on the problem, affected units or actions required.

The Federal Institute for Drugs and Medical Devices (BfArM) has published an Urgent Field Safety Notice from FIM MEDICAL SAS covering the Audiolyser ADL Connect. The entry is dated 29 October 2026 and carries the reference 49653/26.

BfArM classifies the product under medical electronics and electromedical devices, specifically ENT equipment. Its description does not say what the issue is, which devices or batches are affected, or what users are expected to do.

Instead, the regulator directs readers to the manufacturer's Advisory Notice, attached as a 413KB PDF. BfArM flags that the file does not meet accessibility standards. The substance of the field safety action is therefore only in that document.

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 device already on the market. National authorities such as BfArM often publish these notices on their websites.

What it means for your team

  • Download and read the full manufacturer Advisory Notice; the BfArM listing alone does not establish the nature of the problem or the required action.
  • Check whether Audiolyser ADL Connect devices are held, distributed or used within your organisation or supply chain.
  • If devices are affected, record receipt of the notice and follow the manufacturer's instructions through your quality system, using reference 49653/26 for traceability.

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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