Events

Rappel de Device Recall Odyssey

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 PerMedics, 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
    55280
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1609-2010
  • Date de mise en oeuvre de l'événement
    2010-03-23
  • Date de publication de l'événement
    2010-05-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90462
  • 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,planning,radiation therapy treatment - Product Code MUJ
  • Cause
    Anomaly 1, invalid characters in patient id error: currently, odyssey considers a valid id to be comprised of numbers and/or letters. if a patient id in a study contains a character other than a letter or number (including spaces). odyssey removes the invalid character when moving it to a patient folder. due to this, it is possible that two different patient studies could be listed within odyssey.
  • Action
    A letter dated March 23, 2010 was mailed to customers acknowledging the anomalies and informed the reader that the mandatory version correcting the software will be provided by May 19, 2010. Customers with version 4.4 will receive 4.4.04:t hose with version 4.5 will receive 4.5.04; and those with version 4.6 will receive 4.6.01 containing the corrections to these issues. In the meantime, the following recommendations are provided. For Anomaly I . Invalid Characters in Patient ID Error, it 1s recommended that the users do not create patient IDS that contain characters other than letters or numbers. For Anomaly 2.0dysse.v Muchitle Library Collimator Type Error, it is recommended that the customer contact PerMedics ifany modifications to the library have been performed. The primary view should also be examined and used to detect and avoid the conditions causing the anomaly. Finally, independent field shape and monitor unit checks should be performed as part of a routine quality assurance program. For Anomaly 3, OOdyssey MLC Block Error, it is recommended to avoid using the MLC Block feature until the mandatory version correcting this anomaly is installed. If you need to use this feature, then it is recommended that a physical block tray is used during treatment for each beam that contains an Odyssey MLC Block. If customers believe a patient treatment has been affected by any of these issues, they should notify Customer Support as soon as possible at 877-4PerMed (877-473-7633) or support@permedics.com

Device

Device Recall Odyssey
  • Modèle / numéro de série
    Version 4.4 through 4.6
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including NY, GA, CA, MA, and countries of Brazil, Hungary, China, India, Italy, Mexico.
  • Description du dispositif
    Odyssey || Intended use: Radiation treatment planning system
  • Manufacturer
    PerMedics, Inc.

Manufacturer

PerMedics, Inc.
  • Adresse du fabricant
    PerMedics, Inc., 1425 Victoria Ct, San Bernardino CA 92408-2853
  • Société-mère du fabricant (2017)
    PerMedics Inc
  • Source
    USFDA