Events

Rappel de Device Recall Viasys Vela Adult/Pediatric Lung Ventilator

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 Viasys Respiratory Care, Inc.dba Bird Products.

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
    37318
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0638-2007
  • Date de mise en oeuvre de l'événement
    2007-01-31
  • Date de publication de l'événement
    2007-03-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-09-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50340
  • 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
    Ventilator - Product Code CBK
  • Cause
    The graphical user interface may become slow in its response and in some cases non-responsive. under some circumstances this situation may cause the ventilator to delay the annunciation of alarms.
  • Action
    On January 31, 2007, a product notification letter was mailed to all customers in the United States via overnight carrier (Federal Express). Consignees are informed in the notification letter that service calls are in process of being scheduled to update domestic consignees. On January 31, 2007, a product notification kit (including a product notification letter, download software, download instruction sheets and installation verification fax-back sheets) were mailed to all international customers via register mail. Consignees are informed in the notification letter that replacement software, replacement instructions, and installation verification forms are included in their recall package. Domestic Consignees will have product corrected by VIASYS service personnel. Self address postage paid envelopes will be provided with notifications to aid in effectiveness checks

Device

Device Recall Viasys Vela Adult/Pediatric Lung Ventilator
  • Modèle / numéro de série
    Lot numbers: AGT03640 thru AGT06049
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution ---USA and countries of Bangladesh, Bosnia, Brazil, China, Czech Republic, Ecuador, Estonia, Finland, France, Guatemala, Hong Kong, India, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Morocco, Netherlands, Portugal, Russian Federation, Taiwan, Thailand, Turkey & Vietnam.
  • Description du dispositif
    VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc.
  • Manufacturer
    Viasys Respiratory Care, Inc.dba Bird Products

Manufacturer

Viasys Respiratory Care, Inc.dba Bird Products
  • Adresse du fabricant
    Viasys Respiratory Care, Inc.dba Bird Products, 1100 Bird Center Dr, Palm Springs CA 92262-8000
  • Source
    USFDA