Events

Rappel de MAQUET YUNO OTN Mobile Operating Table and Extension Device

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 Maquet Cardiovascular Us Sales, Llc.

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
    65159
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1622-2013
  • Date de mise en oeuvre de l'événement
    2013-04-26
  • Date de publication de l'événement
    2013-07-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118049
  • 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
    Table, examination, medical, powered - Product Code LGX
  • Cause
    Maquet has identified a potential issue with the extension device handle (part number 1433.62a1) and will make enhancements to the yuno table (part number 1433.01f0). identification of the extension device issue: by fully actuating the lever of the extension device handle, the operator's skin can enter a gap between the handle lever and a recess in the handle bar. when the lever is released,.
  • Action
    MAQUET Getinge Group issued an Urgent Medical Device Recall letter/"Field Action Response Form dated April 26, 2013, via Federal Express to all affected customers. The recall notification identifies the product, issue with the product, and measures to be taken by the user. Customers were instructed that the firm would contact them to arrange for a loaner YUNO table and extension device while the table and extension device are upgraded. Upon completion of the upgrades, MAQUET would reinstall their upgraded YUNO table and extension device and remove the loaner device. Customers were instructed to complete and return the enclosed Field Action Response Form, acknowledging their receipt and understanding of the communication by e-mailing a scanned copy to FieldAction@maquet.com or via fax at 973-807-1658. Customers with questions were instructed to contact their MAQUET representative or MAQUET Technical Support at 888-627-8383, option 3, followed by option 1. For questions regarding this recall call 973-709-7691.

Device

MAQUET YUNO OTN Mobile Operating Table and Extension Device
  • Modèle / numéro de série
    YUNO OTN Mobile Operating Table: 1433.01F0 Extension Device: 1433.62A1
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including Arizona, Georgia, North Dakota, South Carolina, Texas and Tennessee, Internationally to United Arab Emirates, Austria, Brazil, Canada, Switzerland, China, Germany, Spain, France, United Kingdom, Italy, Japan, Singapore, Thailand, Turkey, Serbia, and South Africa.
  • Description du dispositif
    MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. || The YUNO OTN is used to support and position patients for surgical procedures immediately before, during and after the surgical phase. The table top is radio translucent and enables intraoperative use of X-ray equipment.
  • Manufacturer
    Maquet Cardiovascular Us Sales, Llc

Manufacturer

Maquet Cardiovascular Us Sales, Llc
  • Adresse du fabricant
    Maquet Cardiovascular Us Sales, Llc, 45 Barbour Pond Drive, Wayne NJ 07470
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA