Z-0767-2021Class II

Eleganza 5 (AC powered adjustable bed), Item Numbers: a) 1GE512055-40, b) 1GE512055-45, c) 1GE512055-85, and...

Name: Z-0767-2021 Eleganza 5 (AC powered adjustable bed), Item Numbers: a) 1GE512055-40, b) 1GE512055-45, c) 1GE512055-85, and...
Creator: Linet Spol. S.r.o.
Published: 2019-11-13
License: https://open.fda.gov/license/

LINET spol. s r.o. / initiated 2019-11-13 / Open, Classified / root cause: design

FDA source

Linet Spol. S.r.o. began a recall of 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... on 2019-11-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0767-2021
Classification: Class II
Status: Open, Classified
Initiated: 2019-11-13
Posted: 2021-01-04
Recalling firm: LINET spol. s r.o.
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.
Product code: FNL Bed, Ac-Powered Adjustable Hospital
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.
Root cause tag: design
FDA root cause: Device Design
Action: The firm initiated the recall by email and hand delivery on 11/13/2019. The notice explains the malfunction and risk, and provides the following information: "Advice on action to be taken by the user: Linet has developed a correction for the side rail mechanism. We will contact you to schedule a Linet or partner technician to update your affected Eleganza 5 Beds with this correction. Until your affected beds are updated, we ask that you follow the safety information as outlined in the Eleganza 5 User manual (D9U001GE5-0101, version: 11, Publication date: 2019-11 (available at your local distributor)) when operating the side rails. Section 11.1 Side rails Chapter MANIPULATION To raise siderails up: >Grab side rail by Side Rail Handle, >Pull side rail up until it latches. You will hear audible "click". If you raise the side rails to the upper position and you find the side rail is not secured and/or no audible click is heard during this operation, take the bed out of service until the bed has been updated." Contact Linet Technical Services at phone no.: 877-815-9897
Quantity in commerce: 518 units
Distribution: US Nationwide distribution.
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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0767-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0767-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-01-13	2021-01-04

Product code FNL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)