Events

Rappel de Harmony Equipment Management System, Model 603X/80XX, STERIS Corporation, Mentor, OH

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Steris Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    66138
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0141-2014
  • Date de mise en oeuvre de l'événement
    2013-08-15
  • Date de publication de l'événement
    2013-11-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121539
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060-1834
  • Société-mère du fabricant (2017)
    Steris Corporation
  • Source
    USFDA