Events

Recall of Device Recall Linet

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
    60857
  • Event Risk Class
    Class 2
  • Event Number
    Z-0738-2012
  • Event Initiated Date
    2011-12-08
  • Event Date Posted
    2012-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106652
  • 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, ac-powered adjustable hospital - Product Code FNL
  • Reason
    The premature failure of the remote handset buttons may result in unintended movement of the bed.
  • 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.

Device

Device Recall Linet
  • Model / Serial
    Model numbers: 1GZ, 1GV, IS, 1GM, 1AG, 1MC and 1L.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of: AL, FL, KY, LA, MA, NC, NY, OH and the country of: Canada
  • Product Description
    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.
  • 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