Events

Rappel de Device Recall FastPlan Versions 5.5 and 5.5.1

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 Varian Medical Systems Oncology Systems.

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
    56024
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0836-2011
  • Date de mise en oeuvre de l'événement
    2010-03-23
  • Date de publication de l'événement
    2010-12-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92440
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Cause
    Due to software issue, an error occurs when performing cone planning using mri, which may result in the patient receiving a higher radiation dose than expected, potentially to healthy tissue.
  • Action
    Varian sent Urgent Medical Device Correction letters on March 23, 2010, by Federal Express to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to run test cases or otherwise determine whether the MR images that they receive have the 'Series Date' parameter populated. Customers should contact their MR system manufacturer to get a confirmation that the 'Series Date' field is populated. Customers were instructed to confirm by visual inspection that the fusion results are loaded appropriately in Cone Planning before starting to create or edit a plan. For questions regarding this recall contact your local Varian Customer Support Distirct or Regional Manager. Phone: USA and Canada - 1-888-VARIANS (888-827-4265) Europe -+41 41 749 8844 E-mail: North America: support-america@varian.com Australia/New Zealand: support-anz@varian.com Europe: support-emea@varian.com South East Asia: seasia.apps.helpdesk@varian.com China/Asia: china.apps.helpdesk@varian.com Japan: Japan.Apps.Helpdesk@varian.com Latin America: soporte.al@varian.com Internet: Oncology Systems customer site - www.myvarian.com Varian Medical System public site - www.varian.com

Device

Device Recall FastPlan Versions 5.5 and 5.5.1
  • Modèle / numéro de série
    All codes start with HZ3: 0001, 0021, 0032, 0033, 0044, 0403, 0404, 0407, 0422, 0426, 0681, 0684, 0698, 0703, 0727, 2035, 2036, 2037, 2039, 2040, 2126, 3020, 3021, 3022, 3026, 9016, 9018, 9066, 9071, 9165, 0054, 0058, 0061, 0077, 0108, 0110, 0111, 0112, 0131, 0139, 0144, 0154, 0167, 0171, 0178, 0182, 0190, 0207, 0208, 0224, 0230, 0251, 0258, 0265, 0273, 0280, 0283, 0293, 0294, 0312, 0330, 0342, 0349, 0368, 0398, 0460, 0461, 0462, 0485, 0495, 0500, 0507, 0508, 0509, 0510, 0511, 0513, 0520, 0531, 0537, 0540, 0556, 0557, 0571, 0572, 0573, 0588, 0594, 0604, 0612, 0617, 0620, 0624, 0630, 0640, 0646, 0649, 0656, 0670, 0675, 0730, 0731, 0737, 0740, 0743, 0762, 2001, 2002, 2003, 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2012, 2013, 2014, 2016, 2017, 2018, 2018, 2020, 2021, 2022, 2024, 2025, 2026, 2027, 2028, 2029, 2032, 2033, 2034, 2042, 2044, 2045, 2046, 2047, 2048, 2049, 2050, 2051, 2052, 2053, 2054, 2055, 2056, 2058, 2059, 2060, 2061, 2062, 2063, 2064, 2065, 2067, 2069, 2071, 2072, 2073, 2074, 2075, 2076, 2077, 2084, 2086, 2108, 2125, 3030, 3031, 3039, 3041, 3042, 3044, 3046, 3047, 3049, 3050, 3053, 3055, 3059, 3062, 3064, 5070, 6101, 6102, 6302, 6303, 7002, 7003, 7005, 7007, 7010, 7011, 7015, 7027, 7101, 8006, 8062, 9002, 9004, 9007, 9010
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution - USA nationwide and the countries of Australia, Brazil, Canada, Chile, Colombia, Georgia, Germany, Hong Kong, India, Ireland, Japan, Macau, Malaysia, Russia, Singapore, Spain, Sri Lanka, and Taiwan
  • Description du dispositif
    Varian Medical Systems FastPlan software, Versions 5.5 and 5.5.1, Model Number HZ3, manufactured by Varian Medical Systems, Palo Alto, CA || Treatment Planning System is intended as aid in quickly and precisely planning the radiation treatment of small cranial lesions such as an asteriovenous malformations, pituitar tumors, pincalomas, acoustic neuromas and malignant neoplasms.
  • Manufacturer
    Varian Medical Systems Oncology Systems

Manufacturer

Varian Medical Systems Oncology Systems
  • Adresse du fabricant
    Varian Medical Systems Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Société-mère du fabricant (2017)
    Varian Medical Systems Inc
  • Source
    USFDA