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MEQU A/S warns of overheating risk in °M Warmer due to misplaced internal seal

🇳🇱 IGJ · Thu 05 Nov 2026

The Dutch inspectorate has published the manufacturer's field safety notice, which links overheating of the °M Warmer to a misplaced seal causing an internal fluid leak.

The Dutch healthcare inspectorate, IGJ, has published a manufacturer warning from MEQU A/S about its °M Warmer. The company has received reports of the device overheating.

According to the notice, the manufacturer's investigation found that the failure stemmed from a misplaced seal in the device's fluid path. This lets fluid leak inside the °M Warmer, which may cause it to overheat.

The field safety notice (FSN) is dated 25 June 2026. IGJ's English-language PDF of the warning runs to four pages. The page text available here does not set out the corrective actions, the affected serial numbers or lots, or any patient harm linked to the reports. Those details are presumably in the full notice.

IGJ notes that manufacturers must monitor their devices after they reach the market and improve them where necessary. Where a risk to users arises, the manufacturer must act and inform users and the inspectorate through a field safety notice.

What it means for your team

  • Organisations using the °M Warmer should obtain the full FSN from IGJ or MEQU A/S and check whether their units are affected.
  • Quality and risk teams should confirm what user actions the notice requires, as these are not stated in the summary.
  • Regulatory and vigilance teams should log the FSN (dated 25 June 2026) and check for any local reporting or follow-up obligations.

Official source: IGJ ↗

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

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