Events

Rappel de YSIO MAX

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 Siemens Medical Solutions USA, 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
    75126
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0015-2017
  • Date de mise en oeuvre de l'événement
    2016-08-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150055
  • 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
    System, x-ray, stationary - Product Code KPR
  • Cause
    Siemens became aware of a potential issue with the patient table for ysio max and multix fusion systems. there is an unlikely risk that an internal part of the table may detach causing the table top to tilt to the left side which could result in an injury to a patient on the table.
  • Action
    Siemens sent a Customer Safety Advisory Notice letter dated August 4, 2016 to their customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to discontinue use of the tables until one of their service technicians can inspect the affected part of each table.

Device

YSIO MAX
  • Modèle / numéro de série
    Model Number: 10762470, 10893300, 10746665 Serial Numbers: 24644,24613,24615,40328,24611,24612,24614,40326,40322,40316,24599,24600,40404,24634,2464124590,40402,1314,40312,24591,24592,40327,40323,24656,24659,40335,1315,40332,40403,24605,40325,40313,24645,24610,24580,24648,24581
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    YSIO Max || Product Usage: || The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA