Events

Rappel de Synergy XVI kV Generator

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
    60497
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0342-2012
  • Date de mise en oeuvre de l'événement
    2011-10-20
  • Date de publication de l'événement
    2011-12-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105583
  • 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
    A small number of sites have experienced situations with kv generator transformers overheating due to a diode failure on the interface board.
  • Action
    The firm, Elekta, issued a "FIELD CHANGE ORDER MANDATORY ACTION" notice dated October 20, 2011 to its customers to add fuse protection for the kV transformers. The notice describes the product, problem, provides instructions and procedures and actions to be taken. The customers were instructed to follow any instructions or recommendations covered in the notice and to file the document in the Important Notice section of the appropriate User Manual. Elekta will contact the customer if the FCO is applicable to their kV generator. If you have any questions, call 770-300-9725.

Device

Synergy XVI kV Generator
  • Modèle / numéro de série
    G30369, G29103, G34727, G32313, G30367, G29101, G31330, G34401, G32304, G30962, G30610, G30668, G29986, G28427, G28581, G28673, G28430, G28755, G28576, G28574, G28676, G28678, G28811, G28763, G28806, G28863, G28809, G28864, G28936, G29035, G29042, G30720, G28929, G29043, G29102, G28421, G29296, G29299, G29843, G31188, G29832, G29838, G29844, G29840, G29983, G30300, G30027, G29980, G30210, G30213, G30034, G30208, G30309, G30310, G30530, G30533, G30558, G30565, G32986, G30606, G30611, G30961, G30718, G30662, G30717, G31397, G31326, G31186, G31190, G31323, G29842, G34393, G31404, G31512, G31522, G31518, G31515, G31517, G30073, G32359, G32363, G32305, G32364, G32366, G32385, G32425, G32389, G32501, G32680, G32682, G32809, G32814, G34285, G32905, G32820, G32821, G32824, G32904, G32908, G33335, G33339, G33338, G33428, G33433, G34150, G34288, G34151, G34159, G34290, G34348, G34347, G34350, G34397, G34501, G34684, G34502, G34505, G34689, G30974, G34691, G34980, G34983, G34726
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: USA including states of: AL, AK, AZ, CA, CT, FL, GA, IL, IA, KY, MD, MS, MI, MN, MS, MO, MT, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TX, VT, VA, WA, WV, WI, Puerto Rico, & DC.
  • Description du dispositif
    Elekta Synergy XVI X-ray Volume Imaging System || To be used as part of radiation therapy treatment process.
  • 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