Events

Rappel de Accessory Head Rest for Alphastar Operating Tables

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 Inc..

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
    49545
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0161-2009
  • Date de publication de l'événement
    2008-10-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-04-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73774
  • 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
    Ac-Powered Operating-Room Table - Product Code FQO
  • Cause
    During installation or cleaning there is a risk of crushing the finger by handling the head rest in the area of the gas strut while simultaneously actuating the release lever.
  • Action
    Urgent Device Correction letters were sent beginning September 26, 2008 via Fed Ex. Letters identified the potential for finger crush in conjunction with the head rest. Proper operating instructions are provided as well as a warning sticker to be applied to the head rest indicating proper positioning. All letters included a customer response form to be completed by each institution. Information requested is: that device correction letter has been read and instructions followed; that the corrected operating instructions have been received; that the warning sticker has been properly placed on the headrest, or that they do not have the head rest identified in the device correction letter. Questions should be addressed to USA Maquet Inc at 1-888-627-8383 #1.

Device

Accessory Head Rest for Alphastar Operating Tables
  • Modèle / numéro de série
    USA Part Number 1130.67F0, No serial numbers
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Accessory Head Rest for Alphastar Operating Tables
  • Manufacturer
    MAQUET Inc.

Manufacturer

MAQUET Inc.
  • Adresse du fabricant
    MAQUET Inc., 1140 Us Highway 22 Ste 202, Bridgewater NJ 08807-2958
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA