Events

Recall of Overhead Rail System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hill-Rom, 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
    62334
  • Event Risk Class
    Class 2
  • Event Number
    Z-0872-2013
  • Event Initiated Date
    2012-10-31
  • Event Date Posted
    2013-02-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110244
  • 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
    Lift, patient, non-ac-powered - Product Code FSA
  • Reason
    Liko/hill-rom to date has received two reports from facilities alleging that the overhead rail system has failed to the extent that the overhead rails have fallen down while in use in high humidity (swimming pool) areas. analysis of the incidents suggest that the components (hardware) used to secure the rail to the ceiling had corroded and may be unsuitable for environments with an atmosphere con.
  • Action
    Liko, a Hill-Rom company, sent an URGENT MEDICAL DEVICE RECALL notice dated October 31, 2012 to all affected customers. Letter identified the affected product, problem and actions to be taken until a new design is finalized and the field corrective action implemented. The letter instructed customers to complete and return the Response Form immediately even if you do not have any rail systems in a chlorinated environment. For questions concerning this request or the procedure as outlined, please contact Hill-Rom Technical Support at 800-445-3720.

Device

Overhead Rail System
  • Model / Serial
    The Liko Overhead Rail System components are not serialized and have been distributed since the early 1980's to the present.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY; and CANADA LOCATIONS: AB, BC, MB, NB, NS, ON, and SK.
  • Product Description
    Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall, Multirall and Masterlift Systems || Product Usage - The Overhead Rail System allows overhead lifts to be mounted to the ceiling allowing versatility for use in lifting situations. It can be used with different Liko ceiling lifts.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Manufacturer Address
    Hill-Rom, Inc., 1069 State Route 46 East, Batesville IN 47006-7520
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA