FDA recall Z-0767-2021

Linet Spol. S.r.o. · Class II · device

Product

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.

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2019-11-13
Report date
2021-01-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Slany, Czech Republic

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0767-2021