Events

Rappel de Harmony Insight Diagnostic Monitor Support System

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
    75385
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0746-2017
  • Date de mise en oeuvre de l'événement
    2016-10-05
  • Date de publication de l'événement
    2016-12-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150180
  • 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
    Lamp, surgical - Product Code FTD
  • Cause
    The drager pendula spring arm device has a set of screws located on the spring arm that were not properly secured with loctite and may become loose.
  • Action
    Steris sent an Urgent Voluntary Field Correction Notice to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remind staff personnel that Harmony Insight Diagnostic Monitor Support Systems, including the affected Drager Pendula spring arms, are not designed or intended to be placed over hospital personnel or patients and should be moved with care. Customers with questions were instructed to call 440-392-7358 or Steris Customer Service at 1-800-548-4873. For questions regarding this recall call 440-392-7231.

Device

Harmony Insight Diagnostic Monitor Support System
  • Modèle / numéro de série
    0419016160 0421416123 0420816119 0415216095 0409016039 0409016038 0404716127 0434815015 0429915001 0429915002 0418015066 0418015065 0416815002 0416015002 0416015001 0413515012 0409615011 0407615001 0407615002 0405015102 0429614003 0401515015 0431714001 0430914002 0430914001 0427614022 0428014006 0423914014 0421714007 0416814001 0415014002 0414314082 0413914001 0412714043 0411414001 0411414003 0411414002 0411114001 0401614001 0404814128 0405014014 0403814116 0402214076 0401314131 0401514013 0400614027 0434413019 0433813017 0429113164 0430113149 0427313064 0417013083 0414813001 0412113002 0412113001 0410013001 0405213038 0404413018 0404413017 0404413016 0404413016 0436112019 0436112018 0434912001
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including AK, AZ, CA, CO, FL, IL, KY, MI, MO, NB, NJ, NY, OH, PA, RI, SD, TN, TX, UT, WA & WV.
  • Description du dispositif
    Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) || The system is intended for use in surgical operating rooms (OR) or intraoperative surgical/imaging rooms where simultaneous multiple image viewing is required
  • 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