Events

Recall of Device Recall Liko AB Uno Lifts

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Liko North America 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
    50155
  • Event Risk Class
    Class 2
  • Event Number
    Z-0606-2009
  • Event Initiated Date
    2008-11-11
  • Event Date Posted
    2009-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74871
  • 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
    Non-Ac-Powered Patient Lift - Product Code FSA
  • Reason
    Actuator of the lift has the potential to separate when the upper arm is fully extended.
  • Action
    Hill Rom notified customers with a Field Safety Notice, dated December 5, 2008 to notify customers of the issue, potential risks, and to inspect units per their instructions and remove units from service if the unit fails inspection. Hill-Rom will provide a permanent fix, using an "OuterTube" to be placed on all units.

Device

Device Recall Liko AB Uno Lifts
  • Model / Serial
    Old Uno 102: S/N 20001 through 21300 New Uno 102: S/N 30001 through 48100 Production Dates: Manufactured prior to June 26, 2008
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and country of Canada.
  • Product Description
    Liko AB Uno Lifts, Powered (non-AC) Patient Lift: || Old Uno 102: S/N 20001 through 21300 || New Uno 102 EM/EE/ES: S/N 30001 through 48100 || Production Dates: Manufactured prior to June 26, 2008 || Uno 100 and 102 are battery powered mobile lifts, designed to be used in most of the common lifting situations, for example transfers between bed and wheelchair, to and from the toilet and bathtub or for lifting to and from the floor.
  • Manufacturer
    Liko North America Inc

Manufacturer

Liko North America Inc
  • Manufacturer Address
    Liko North America Inc, 122 Grove St, Franklin MA 02038-3159
  • Source
    USFDA