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BfArM publishes urgent field safety notice for Batec handbike models by Batec Mobility

🇩🇪 BfArM field safety notices · Wed 04 Nov 2026

The German regulator has posted a manufacturer notice covering the Electric 2, Rapid 2 and Scrambler 2 handbike attachments, though the hazard and required actions are not stated in the listing.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice on 4 November 2026 from Batec Mobility, S.L. The notice covers the company's Batec handbike products: Electric 2, Rapid 2 and Scrambler 2.

BfArM lists the item under reference 46943/26 and places it in the product group of orthopaedic and rehabilitation technology, specifically mobility aids.

The BfArM entry is brief. It does not describe the defect, the risk to users or any corrective action. It refers readers to the manufacturer's Advisory Notice, which is attached as a 641 KB PDF. BfArM flags that the file does not meet accessibility standards.

Details such as affected serial numbers or batches, the nature of the problem and instructions for users or distributors are therefore not available from the BfArM text and must be taken from the manufacturer's document.

As general context, a field safety notice is the communication a manufacturer sends to customers or users when it takes a field safety corrective action on a medical device on the market. Regulators typically publish these notices to make them publicly accessible.

What it means for your team

  • Distributors, rehabilitation suppliers and healthcare providers handling Batec Electric 2, Rapid 2 or Scrambler 2 units should obtain and read the full Advisory Notice from the BfArM page.
  • The scope, hazard and required actions cannot be assessed from the BfArM listing alone, so teams should not infer them.
  • Quality and vigilance teams may wish to log reference 46943/26 and check whether affected products are in their supply chain or customer base.

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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