Events

Rappel de Device Recall LANTIS software

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
    34166
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0364-06
  • Date de mise en oeuvre de l'événement
    2005-01-06
  • Date de publication de l'événement
    2006-01-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-05-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43217
  • 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
    When using the creatine clearance dose calculations a software bug will allow the algorithm to assume a patients age to be in years when it is entered in months. this miscalculation may result in patients less than two years old to be seriously overdosed with radiation.
  • Action
    The firm has sent out notification letters to the 18 sites with the activated MedOnc option. All 18 site had the letters delivered by Siemens Medical Solutions field service personnel by 1/6/2005.

Device

Device Recall LANTIS software
  • Modèle / numéro de série
    Serial #: 93-0001, 93-0016, 93-0027, 93-0289, 93-0304, 93-0306, 93-0333, 93-0368, 93-0430, 93-0436, 93-0549, 93-0639, 93-0641, 93-0652, 93-0664, 93-0703, 93-0718 and  93-0786
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    A total of 18 sites were identified by the firm as having the MedOnc module activated; 6 within the United States U.S.) and 12 outside of the U.S.
  • Description du dispositif
    LANTIS software with MedOnc Module; || MedOnc module is an option of the LANTIS radiotherapy treatment planning software distributed as a component of the firm''s linear accelerator used to deliver radiation therapy to cancer patients. || The MedOnc module is distributed by Siemens Medical Solutions USA ¿ Oncology Division, 4040 Nelson Avenue, Concord, CA 94520 with their linear accelerators software package called LANTIS. The MedOnc module option is distributed with all LANTIS software copies, but the module must be turned on by an electronic key that is purchased by individual hospitals. || Siemens Medical Solutions USA purchases the LANTIS software (code) from IMPAC Medical Systems, Inc., 100 West Evelyn Avenue, Mountain View, CA 94041 (REG#2950347, FEI: 1000123805). IMPAC distributes the same software under the name SEQUENCER.
  • 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