Events

Recall of HillRom Likorall 200

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
    75197
  • Event Risk Class
    Class 2
  • Event Number
    Z-0326-2017
  • Event Initiated Date
    2016-08-09
  • Event Date Posted
    2016-10-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149635
  • 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
    Ceiling bracket 71 was shipped with a larger center hole. a potentially hazardous situation exists that if the ceiling bracket 71 with a larger center hole is used for a concrete ceiling ultra system installation with the m8 screw and the safe working load is exceeded, the system could fall.
  • Action
    On 8/9/2016, URGENT: MEDICAL DEVICE CORRECTION notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If you have any questions regarding this Field Safety Correction, please contact Hill-Rom Technical Support at 1-800-445-3720, your distributor or your Hill-Rom representative.

Device

HillRom Likorall 200
  • Model / Serial
    manufacturing date between Dec 01, 2015- Apr 14, 2016
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    WA NC OH PA MI Australia Sweden
  • Product Description
    Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling || installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, || and LikoGuard L and XL.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

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