RecallRadar

FDA Device recall Z-0767-2021

Eleganza 5 (AC powered adjustable bed), Item Numbers: a) 1GE512055-40, b) 1GE512055-45, c) 1GE512055-85, and d) 1GE512055-95 - Product Usag…

On 2021-01-13 the FDA classified a Class II recall of Eleganza 5 (AC powered adjustable bed), Item Numbers: a) 1GE512055-40, b) 1GE512055-45, c) 1GE512055-85, and d) 1GE512055-95 - Product Usag… by Linet Spol S R O, citing 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 th….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0767-2021
ClassificationClass II
Statusongoing
Initiated2019-11-13
Published2021-01-13
Last updated2026-09-13 11:56 UTC
CompanyLinet Spol S R O
DistributionUS

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

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.

Identifiers

code_info
a) 1GE512055-40: 20170042941, 20170042942, 20170042943, 20170042944, 20170042945, 20170042946, 20170043764, 2017004376…a) 1GE512055-40: 20170042941, 20170042942, 20170042943, 20170042944, 20170042945, 20170042946, 20170043764, 20170043765, 20170043766, 20170043767, 20170043768, 20170043769, 20170043770, 20170043771, 20170043772, 20170043773, 20170043774, 20170043775 b) 1GE512055-45: 20170055478, 20170055479, 20170055480, 20170055481, 20170055482, 20170055483, 20170055484, 20170055485, 20170055486, 20170055487, 20170055488, 20170055489, 20170055490, 20170056038, 20170056039, 20170056040, 20170056041, 20170056042, 20170056043, 20170056044, 20170056045, 20170056046, 20170056047, 20170056048, 20170056049, 20170056050, 20170056051, 20170056052, 20170056053, 20170056054, 20170056055, 20170056056, 20170056527, 20170056528, 20170056529, 20170056530, 20170056531, 20170056532, 20170056533, 20170056534, 20170056535, 20170056536, 20170056537, 20170056538, 20170056539, 20170056540, 20170056541, 20170056542, 20170056543, 20170056544, 20170056545, 20170056546, 20170058170, 20170058171, 20170058172, 20170058173,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0767-2021%22

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