Events

Rappel de Device Recall ONCOR Expression

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
    38516
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0165-2008
  • Date de mise en oeuvre de l'événement
    2007-03-22
  • Date de publication de l'événement
    2007-11-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-12-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65672
  • 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
    Medical Digital Linear Accelerator - Product Code IYE
  • Cause
    Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in service mode. the miss-calibration can affect the beam profile and virtual wedge angle. this leads to patient mistreatment and alteration of future treatment plans. a second reason is an unplanned dosimetry calibration data set can be erroneously copied during "service mode.".
  • Action
    Distribution of Update Instructions TH007/07/S was sent to all affected sites on March 26, 2007. This was intended to inform users that Service Mode is only for use by authorized personnel, and that unauthorized and/or incorrect softpot parameter changes performed in Service Mode can result in the risk of patient mistreatment. Current control system software versions do not allow unplanned Dosimetry calibration data sets to be erroneously copied during "Service Mode."

Device

Device Recall ONCOR Expression
  • Modèle / numéro de série
    MODEL NUMBERS: 7360204, 7360717 : Serial Numbers: 5029, 5037, 5042, 5094.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide:USA including states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virgina, Wisconsin, and Wyoming and FOREIGN COUNTRIES: Canada, Mexico, Serbia Montenegro, Angola, Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Herzeg-Bosnia, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, DPR of Korea, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Malaysia, Morocco, Nepal, Netherlands, New Zealand, Norway, P.R. China, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uzbekistan, Venezuela, Vietnam, and Zambia
  • Description du dispositif
    ONCOR Expression,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBERS: 7360204 and 7360717, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
  • Source
    USFDA