FDA-Device2021-01-13Class II
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.
Linet Spol. S.r.o.
Hazard
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.
Sold states
US Nationwide distribution.
Affected count
518 units
Manufactured in
Zelevcice 5, Slany, Czech Republic
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0767-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief