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AEMPS warns of incomplete locking risk in Winncare LUNA X5 ceiling lift carriages

🇪🇸 AEMPS · Fri 23 Oct 2026

Spain's regulator says some LUNA X5 carriages used in portable configuration with an extension arm may not lock fully, risking a hoist fall and injury during patient transfers.

The Spanish Agency for Medicines and Medical Devices (AEMPS) has published safety note PS, 44/2026 on a risk of incomplete locking in certain LUNA X5 carriages for ceiling lifts. The agency learned of the issue from the manufacturer, Winncare Nordic ApS. The carriages are used with LUNA X5 or LUNA IPX4 ceiling lifts.

According to AEMPS, the problem can arise when the equipment is used in a portable configuration with an extension arm. If the strap bayonet is attached differently from the way the user manual describes, it may sit only partly locked in the carriage in an unstable position. A transfer or a sudden jolt could then cause the hoist to fall, injuring the patient, the user or other people.

The affected product is the Winncare ceiling-lift carriage, type 85 & 125 – LUNA X5, reference 016-02130, UDI-DI 05740008103062. Units placed in service between 17 June 2025 and 15 June 2026 are covered. In Spain the product was distributed by Winncare Spain, S.L.U., which is sending a notice to distributors, orthopaedic suppliers and users.

The manufacturer has developed a kit that makes the coupling easier and produces an audible click when the bayonet is correctly locked. Users are asked to check full locking before every transfer and, if they cannot confirm it, not to start the transfer and to seek help. They should request the kit through their distributor by completing Annex 1 of the notice and returning it within six months of receiving the notice.

Distributors and orthopaedic suppliers are asked to identify which affected carriages they hold, check whether these are used in portable configuration, and record the units and recipients. They should also forward the notice to customers and pass on requests for training or kits. AEMPS reminds readers to report incidents through its NotificaPS portal.

What it means for your team

  • Distributors and orthopaedic suppliers should trace affected units (reference 016-02130, in service 17 June 2025 to 15 June 2026) and document recipients, as AEMPS asks.
  • Quality and field-action teams should note the preventive remedy is a coupling kit, with a six-month window for users to return the request form after receiving the notice.
  • Vigilance teams should route any incidents linked to these carriages to AEMPS through NotificaPS.
  • Healthcare facilities should check use in portable configuration with an extension arm, where the risk is described, and ensure staff verify full bayonet locking before each transfer.

Official source: AEMPS ↗

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

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