PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: January 13, 2021 Initiated: November 13, 2019 #Z-0767-2021

Product Description

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.

Details

Recalling Firm
Linet Spol. S.r.o.
Units Affected
518 units
Distribution
US Nationwide distribution.
Location
Slany

Frequently Asked Questions

What product 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.. Recalled by Linet Spol. S.r.o.. Units affected: 518 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 13, 2021. Severity: Moderate. Recall number: Z-0767-2021.