PharmacovigilanceOfficial

FIM Medical warns of ADL Connect audiometer emitting louder 250 Hz tone than selected

🇳🇱 IGJ · Tue 10 Nov 2026

The Dutch inspectorate has published a manufacturer field safety notice after two reports of the Audiolyser ADL Connect producing a 250 Hz tone far above the level set in Audiowin software.

The Dutch healthcare inspectorate IGJ has published a manufacturer warning on the Audiolyser ADL Connect, an audiometer made by FIM MEDICAL SAS. The company says it has received two reports of the device emitting a tone at 250 Hz at a level much higher than the one chosen in the Audiowin software.

The field safety notice (FSN) is dated 22 October 2026. IGJ makes it available as a four-page PDF in English alongside its Dutch-language listing. The summary text does not say how the reports came to light or whether any patient was affected.

An unexpectedly loud test tone is a safety concern in audiometry because the equipment is used to present controlled sound levels to patients. The published text does not specify the corrective actions, the affected serial numbers or software versions, or any timelines. Those details are in the FSN itself.

IGJ notes that manufacturers must monitor their devices after they reach the market and act when a risk to users emerges. Field safety notices are the way manufacturers inform users and the inspectorate of such action.

What it means for your team

  • Device vigilance teams and users of the ADL Connect should read the full FSN dated 22 October 2026 to identify the required actions and affected units.
  • Audiology clinics using Audiowin with the ADL Connect should check the notice and review their own records for any unexpected high-level 250 Hz output.
  • Quality and regulatory teams should log the FSN and confirm that the manufacturer's instructions are implemented and documented.
  • Any similar incidents should be reported through the usual vigilance channels, as the manufacturer has so far cited only two reports.

Official source: IGJ ↗

Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.

More Pharmacovigilance All →