Events

Rappel de Device Recall Harmony LA/LED Arm Adapter

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
    58107
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1886-2011
  • Date de mise en oeuvre de l'événement
    2011-02-18
  • Date de publication de l'événement
    2011-04-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-03-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98365
  • 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
    Light, surgnical, ceiling mounted - Product Code FSY
  • Cause
    The arm adapter does not contain labelling specifying the applicable weight and moment limitations of the arm adapter.
  • Action
    Steris Corporation sent an Urgent Field Correction Notice letter dated February 18, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A Steris representative would contact customers to arrange for replacement of the product. For questions regarding the firms visit to their facility, customers were instructed to contact Steris Field Service Dispatch at 1-800-333-8828. For any questions regarding this matter call 440-392-7705.

Device

Device Recall Harmony LA/LED Arm Adapter
  • Modèle / numéro de série
    Model Number: LB61
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including CO, IL, IN, MO, NC, NV, NY and OH and the countrries of Canada, China, and Australia.
  • Description du dispositif
    Harmony LA/LED Monitor Arm Adapter. Model Number: LB61 || The Harmony LA/LED Monitor Arm Adapter is an accessory to the Harmony LA and LED Surgical Lighting System and is attached to the end of the monitor suspension arm to allow Customers to attach other medical devices, such as non-STERIS monitors, camera or other compatible items in place of the STERIS monitor. The Harmony Surgical Lighting and Media System is a family of variable pattern, variable intensity surgical lights designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. The device is intended to be used by surgeons and other medical care practitioners in a surgical setting
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Adresse du fabricant
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060
  • Société-mère du fabricant (2017)
    Steris Plc
  • Source
    USFDA