Quality & complianceOfficial

Batec Mobility asks users to apply 20 km/h speed limit on Handbike platform 2 models

🇳🇱 IGJ · Mon 09 Nov 2026

The Dutch inspectorate has published a manufacturer field safety notice asking for preventive speed limiting on all Batec Handbikes platform 2 models, citing a new version of EN 12184.

The Dutch Health and Youth Care Inspectorate (IGJ) has posted a manufacturer warning from Batec Mobility S.L. covering its Handbike Batec products. The company is requesting preventive application of a speed limit of 20 km/h on all Handbikes platform 2 models.

The notice refers to a new version of the standard EN 12184:2022, which applies from 27 May 2028. The source gives no further detail on how the standard relates to the requested limit, and does not describe any incidents or specific hazards.

The Field Safety Notice (FSN) is dated 29 April 2026. IGJ published it on its website with a posting date of 10 November 2026, together with a five-page English-language PDF of the notice.

IGJ explains that manufacturers must monitor medical devices after they reach the market and improve them where needed. Where users face a risk, the manufacturer must act and inform users and the inspectorate through a field safety notice.

What it means for your team

  • Owners and distributors of Batec Handbikes platform 2 models should check the full FSN and apply the 20 km/h limit as requested.
  • Quality and regulatory teams in the mobility-device sector should note that EN 12184:2022 has a new version applying from 27 May 2028.
  • Distributors should keep records of how affected customers were informed and what action was taken, in line with field safety corrective action practice.

Official source: IGJ ↗

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

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