Events

Recall of Harmony Equipment Management System, Model 603X/80XX, STERIS Corporation, Mentor, OH

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

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
    66138
  • Event Risk Class
    Class 2
  • Event Number
    Z-0141-2014
  • Event Initiated Date
    2013-08-15
  • Event Date Posted
    2013-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121539
  • 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
  • Reason
    Dr¿ger medical gmbh has notified steris of the potential for a break in the drive screw contained in the motorized ceiling supply unit, a component of the harmony ems system. the ceiling supply unit controls the motorized adjustment of the height and rotation of the supply column. should a break occur in the drive screw, there is potential for the adjustable arm to drop down, causing the ems sys.
  • Action
    STERIS sent an Urgent Voluntary Field Correction Notice dated August 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. STERIS action- Drager Medical has provided STERIS instructions for inspection of the alignment of the mounting plate of the motor unit. If it is found that the mounting plate is bent, the drive screw within the motor unit must be replaced. STERIS will visit your facility to inspect the motorized ceiling supply unit of your Harmony EMS system(s) and if damage is observed, will replace the drive screw within the motor unit. For further information or if you have any questions regarding our visit to your facility, please contact STERIS Field Service Dispatch at 1-800-333-8828.

Device

Harmony Equipment Management System, Model 603X/80XX, STERIS Corporation, Mentor, OH
  • Model / Serial
    Serial numbers 0422503114 - 0426604096
  • Distribution
    Nationwide distribution: USA including the states of Alabama, Arkansas, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Virginia, Washington and Wisconsin.
  • Product Description
    Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH || Harmony Equipment Management Systems (EMS) are used in hospital facilities to provide ready access to medical gasses, electrical power and audio/visual data services, in addition to managing surgical support equipment such as endoscopic equipment, cautery devices and insufflators.
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Manufacturer Address
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060-1834
  • Manufacturer Parent Company (2017)
    Steris Corporation
  • Source
    USFDA