Events

Recall of Device Recall Eleganza 3 Hospital Bed

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Linet Americas Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58785
  • Event Risk Class
    Class 2
  • Event Number
    Z-2411-2011
  • Event Initiated Date
    2011-05-02
  • Event Date Posted
    2011-06-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100295
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Bed, hydraulic, adjustable hospital - Product Code FNK
  • Reason
    Linet has been made aware that there has been breakage of the mobi-lift handle on a few beds which may cause failure during patient assist use.
  • Action
    The firm, Linet America, notified US customers only via phone on May 5, 2011. A follow up "service advisory information" letter dated May 11, 2011 was sent to all customers. The letter described the product, problem and action to be taken. The customers were instructed to remind/retrain staff to ensure that the Mobi-lift handles are always in the stowed position during patient transport and after use, and complete and return the attached Inspection procedure for each affected Eleganza 3 bed via mail to: Linet Americas, 10420-R Harris Oaks Blvd., Charlotte, NC 28269 or fax to: 704-248-5655. Linet Americas will be receiving a supply of new Mobi-lift design and will begin the process of executing service calls to replace the Morbi-lift handles with the new design. If you have any questions, contact the Director of Quality and Service Operations at 704-248-5650 or 980-406-6446.

Device

Device Recall Eleganza 3 Hospital Bed
  • Model / Serial
    Models: Eleganza 3 (1GZ17045 with Scale) or (1GZ07045 without Scale), Accesory: Mobi-lift handle (P/N D310105B) (Located towards the foot side of bed on both sides), Serial Numbers: 20100043034 to 20100043045
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: KY, MA, NC, and NY; and country of: Canada.
  • Product Description
    Eleganza 3 Hospital Bed || Intended use: AC Powered adjustable Hospital Bed
  • Manufacturer
    Linet Americas Inc

Manufacturer

Linet Americas Inc
  • Manufacturer Address
    Linet Americas Inc, 10430 Harris Oak Blvd, Ste A, Charlotte NC 28269-7511
  • Manufacturer Parent Company (2017)
    Linet Americas Inc.
  • Source
    USFDA