Events

Rappel de Leksell Gamma Knife C

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 Elekta, 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
    55148
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1429-2010
  • Date de mise en oeuvre de l'événement
    2006-08-01
  • Date de publication de l'événement
    2010-04-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-12-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90081
  • 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
    Radionuclide radiation therapy system - Product Code IWB
  • Cause
    Due to a material change in a critical component of the linear actuators the quality of said part was found to be inadequate.
  • Action
    Phase 1 - Technical Notes Leksell Gamma Knife C version 1.2 (dated August 2006) "Potential Problem with Error Handling" was sent to all users. Phase 2 - Mandatory Field Action 0000748, "Helmet Changer Actuator, MTB and MCU SW Upgrade Kit was released December 3, 2007. This Field Change Order includes two mod kits and a software upgrade to provide a permanent solution to the issues. Phase 3 - Technical Note 200 068, "Safety issue with helmet host actuator", released on May 15, 2008. This Technical Note includes a warning to customers of a potential quality problem with the helmet hoist actuator that is installed in the Leksell Gamma Knife. Phase 4 - Mandatory Field Action 200 067, "Investigation and Correction of Helmet Changer Actuators", released on May 15, 2008. This FCO includes a list of user machines which must be monitored for quality issues and provides a solution for replacement of parts should a deficiency be detected. Phase 5 - Mandatory Field Action 200 075, "Helmet Changer Actuator, MTB and MCU SW upgrade, release two", released on September 16, 2008. This FCO applies to machines within specific serial number ranges. Due to a material change in FCO-0000748 and baselines (conducted without notice by the manufacturer) the quality of said part was found to be inadequate. After reversing the material change, FCO 200 075 is released to update the installed base with the new type of actuator and to finish the remaining sites never or partially updated by the now superseded FCO-0000748. For further information, contact Elekta R&D; Jonas Hallstensson on phone no. +46 709 843 553 or via e-mail jonas.hallstensson AT elekta.com.

Device

Leksell Gamma Knife C
  • Modèle / numéro de série
    4148, 4207, 4214, 4300, 4302, 4303, 4306, 4307, 4308, 4309, 4313, 4314, 4315, 4318, 4319, 4321, 4322, 4326, 4327, 4328, 4329, 4332, 4333, 4334, 4337, 4338, 4339, 4340, 4341, 4342, 4343, 4344, 4346, 4351, 4352, 4353, 4354, 4357, 4363, 4365, 4366, 5000, 5003, 5006, 5009, 5010, 5018, 5019, 5022, 5023, 5026
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    AL, CA, CO, CT, FL, GA, IL, MD, MA, MI, MN, MO, NE, NY, NC, OH, OK, OR, PA, TN, TX, VA, WA
  • Description du dispositif
    Leksell Gamma Knife C
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Adresse du fabricant
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    USFDA