Events

Rappel de Device Recall LEKSELL GAMMAPLAN

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
    54890
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1604-2010
  • Date de mise en oeuvre de l'événement
    2008-01-07
  • Date de publication de l'événement
    2010-05-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-12-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89388
  • 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, radiation therapy, radionuclide - Product Code IWB
  • Cause
    The precision of the calculation used to create the fused study in lgp 8.0 is too low and should not be used until the system is upgraded to lgp 8.2.
  • Action
    Phase 1 - Important Notice and Technical Note #200 058 - "Accuracy problems in Leksell GammaPlan 8.0 image fusion", dated December 10.2007 and Field Change Order #200 058, "Technical Note: Accuracy problems in Leksell Gamma Plan 8.0 image fusion", dated January 7, 2008 were sent to affected customers and all field service engineers as notification of the problem. The notice describes the product, problem and actions to be taken by customers. The firm recommended that the customers not use the fusion function until their Leksell GammaPlan(R) is upgraded to version 8.2. For further question, do not hesitate to contact your Elekta support respresentative at

Device

Device Recall LEKSELL GAMMAPLAN
  • Modèle / numéro de série
    2UA7361354, SG50425266, CZC75037DN, SG42820297, CZC707499P, SG34220707, CZC7044FLP, CZC7053FQD, CZC71228QT, CZC7354BN3, CZC740298, SG43520759, SG43720546, SG50825766, 2UA7291VKX, 2UA7291VJ3, US19378673, CZC354BN1, 0703150004, SG23320693, SG24820187, SG52720065, SG31620624, CZC70906S3, CZC70906SB, 2UA7361359, SG52720070, SG44925633, CZC70906S5, CZC7053FQ6, CZC706326M, 2UA736135C, 2UA7291VHT, SG34420200, SG32520836, 2UA7291VHY, 2UA7150VYH, SG43720660, CZC7481Q3R, SG50425271, SG50825764, US68115508, SG52720067, SG34620630, 2UA7251YHM, SG60320067, SG5272066, SG20620611, 2UA73317NW, SG41720274, SG41720317, SG31360678, SG40920412, SG31020317, SG33620363, SG24820212, CZC707499Q, CZC74024P9, SG42520530, CZC07031CRQ, CZC07031CRX, CZC70906S6, CZC70906S7, CZC7044FLN, SG50425273, SG50927332
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: AL, AR, CA, CO, CT, FL, GA, IL MD, MA, MI, MN, MS, MO, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, and WA.
  • Description du dispositif
    Leksell GammaPlan 8.0 image fusion || Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument AB. the Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of the health professions (Neurosurgeons, Radiation therapists, Radiation Physicists) such that the desired radiation does is proved by the Leksell Gamma Knife to a precisely defined target area within the cranium.
  • 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