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AEMPS flags entrapment risk with Let's Get Up and Let's Get Up L bed handles

🇪🇸 AEMPS · Fri 30 Oct 2026

Spain's regulator says a gap between bed and handle may trap users; manufacturer Trust Care AB has paused sales and revised the instructions for use.

The Spanish Agency for Medicines and Medical Devices (AEMPS) has issued a safety note, reference PS, 45/2026, on a possible entrapment risk with the Let's Get Up and Let's Get Up L bed handles. The aids are designed to help users sit up from bed independently. The risk arises if a gap forms between the bed and the device.

AEMPS learned of the issue from the manufacturer, Trust Care AB of Sweden. The company was told by the Swedish competent authority about several serious incidents involving similar products from other manufacturers. It then reviewed the safety of its own devices and decided to temporarily suspend their sale and distribution while it carries out further verification and investigation.

Units already installed in users' homes may stay in use. The manufacturer has, however, identified a need to clarify which beds and mattresses are compatible, and how both products should be installed and used correctly. It has updated the instructions for use with additional safety and compatibility requirements that apply to all devices in use.

The affected products are Let's Get Up (reference LGU101, basic UDI-DI 735003688LGU10076) and Let's Get Up L (reference LGU101L, basic UDI-DI 0735003688LGU101L4R). Trust Care AB distributed them in Spain and is sending a notice to orthopaedic suppliers and users. Users should read the notice, use the updated instructions, confirm correct installation with a compatible bed and mattress, check any gap between mattress and aid as the instructions describe, and report incidents or malfunctions to the manufacturer. Orthopaedic suppliers should contact customers who received the affected products and pass on the company's notice. AEMPS also asks that incidents be reported through its NotificaPS portal.

What it means for your team

  • Manufacturers of similar bed-rise aids may expect scrutiny of compatibility and gap-related entrapment risks after the Swedish authority's incident reports.
  • Distributors and orthopaedic suppliers in Spain should trace customers who received the affected references and forward the company's notice.
  • Vigilance teams should route any related incident or malfunction reports to the manufacturer and, in Spain, through NotificaPS.
  • Quality teams should note that the updated instructions for use apply to all devices in use, not only to new supply.

Official source: AEMPS ↗

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

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