Events

Rappel de Device Recall BMSI MicroJack

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 Nicolet Biomedical Div of Viasys Healthcare.

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
    38424
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1225-2007
  • Date de mise en oeuvre de l'événement
    2007-07-17
  • Date de publication de l'événement
    2007-09-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-12-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53645
  • 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
    Electroencephalograph System - Product Code GWQ
  • Cause
    The bmsi "microjack" patient interface electrode connection device used with the eeg monitor systems was found to be mis-wired. a complainant alleged that during depth electrode eeg study of a patient in preparation for brain surgery there was an observation that was perceived as non-logical data output.
  • Action
    VIASYS will initiate a field correction for units that have been distributed. The correction consists of testing the units and replacing those that have been found to contain the defect. Method of communication will be by certiified mail to identify consignees and receipt of the communication will be tracked. Letters "Viasys HealthCare Urgent Medical Device Field Correction (Recall)" were sent 7/17/07 to both domestic and international customers.

Device

Device Recall BMSI MicroJack
  • Modèle / numéro de série
    Models BMSI 2000, 3000, 4000, 5000 & 6000 and BMSI kit upgraded with NicoletOne.
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, including USA, ISRAEL, LITHUANIA, RUSSIA, FRANCE, IRELAND, UNITED KINGDOM , SPAIN, YEMEN, JAPAN, TAIWAN, KOREA, CHINA, SAUDI ARABIA, HONG KONG, INDIA, COLOMBIA, BRAZIL, GERMANY, CANADA, DENMARK, ITALY, MEXICO, and THAILAND.
  • Description du dispositif
    BMSI "MicroJack" PN 672-510000 patient interface electrode connection device used during electroencephalography (EEG) /Epilepsy Monitoring evaluations with various EEG monitoring systems. The MicroJack is used with BMSI Models 2000, 3000, 4000, 5000 & 6000, and is used with the BMSI kit upgraded with NicoletOne. Nicolet Biomedical, Inc.
  • Manufacturer
    Nicolet Biomedical Div of Viasys Healthcare

Manufacturer

Nicolet Biomedical Div of Viasys Healthcare
  • Adresse du fabricant
    Nicolet Biomedical Div of Viasys Healthcare, 5225 Verona Rd, Madison WI 53711-4497
  • Source
    USFDA