Medical device recalls Moderate risk

Linet Spol. S.r.o. recalls Eleganza 5 (AC powered adjustable bed), Item Numbers: a) 1GE512055-40, b) 1GE512055-45, c) 1GE512055-85, and d) 1GE5120…

Recall date
November 13, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0767-2021
FDA classification
Class II
Brand / firm
Linet Spol. S.r.o.
Sold / distributed
US Nationwide distribution.

Why it was recalled

A component used within the side rail mechanism may malfunction, resulting in the side rail either not locking properly in the upper position or the side rail becoming stuck in the upper position.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Eleganza 5 (AC powered adjustable bed), Item Numbers: a) 1GE512055-40, b) 1GE512055-45, c) 1GE512055-85, and d) 1GE512055-95 - Product Usage: Eleganza 5 is a positionable bed for intensive care. Its purpose is to support patient and to facilitate treatment and manipulation with patient for nursing personnel.

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