Z-0738-2012

Linet Remote Handset for model Multicare, Eleganza 3 and Eleganza Smart, hospital bed

Name: Z-0738-2012 Linet Remote Handset for model Multicare, Eleganza 3 and Eleganza Smart, hospital bed
Creator: Linet Americas Inc
Published: 2011-12-08
License: https://open.fda.gov/license/

Linet Americas / initiated 2011-12-08 / Terminated / root cause: manufacturing process

FDA source

Linet Americas Inc began a recall of Linet Remote Handset for model Multicare, Eleganza 3 and Eleganza Smart, hospital bed. Product Usage: Positional hospital bed for acute care. The bed is... on 2011-12-08. The reason FDA records is "The premature failure of the Remote Handset buttons may result in unintended movement of the bed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0738-2012
Status: Terminated
Initiated: 2011-12-08
Posted: 2012-01-13
Terminated: 2012-07-20
Recalling firm: Linet Americas
Product: Linet Remote Handset for model Multicare, Eleganza 3 and Eleganza Smart, hospital bed. Product Usage: Positional hospital bed for acute care. The bed is designed for the care and treatment of inpatients at hospitals and is designed for standard and intensive care.
Product code: FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall: The premature failure of the Remote Handset buttons may result in unintended movement of the bed.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Linet sent a notification letter dated December 9, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken. The letter states that firm Linet has decided to do a voluntary field correction to replace the recalled product. The replacement will be completed by the territory Representative (Linet Employee) who will replace the affected product for each customer personally. The replacement takes approximately 30 seconds and does not require the patient to be moved. For questions or concerns call 704-248-5650.
Quantity in commerce: 29,252 units
Distribution: Worldwide Distribution - USA (nationwide) including the states of: AL, FL, KY, LA, MA, NC, NY, OH and the country of: Canada
Product codes and lots: Model numbers: 1GZ, 1GV, IS, 1GM, 1AG, 1MC and 1L.

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)