Events

Rappel de Device Recall Elekta SL Series/Precise Digital Accelerator.

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
    54559
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1159-2010
  • Date de mise en oeuvre de l'événement
    2005-10-01
  • Date de publication de l'événement
    2010-03-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-03-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88716
  • 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
    Customer reported larger than expected variations in wedge factory with gantry rotation.
  • Action
    Important Notice A280 "Wedge Matching Procedure" (dated 11/18/05) was sent to all effected customers. The Important Notice described the issue, warnings and cautions and corrective instructions/Maintenance to take to eliminate occurrence. Direct questions to your local Elekta Limited representative.

Device

Device Recall Elekta SL Series/Precise Digital Accelerator.
  • Modèle / numéro de série
    Model SL15, Serial Nos. 105102, 105333, 105481, 105279, 1054424, 105325, 105364, 105387, 105291, 105280, 105261, 105297, 105355, 105386, 105342, 105367; Model SL18, Serial Nos. 105213, 105392, 105395, 105326, 105203, 105369, 105284, 105153, 105166, 105324, 105265, 105320, 105177, 105305, 105122, 105199, 105359, 105366, 105126, 105363, 105178, 105233; Model SL25, Serial Nos. 105013, 105204, 105245, 105373, 105376, 105275, 105277, 105127, 105196, 105393, 105186, 105217, 105210, 105117, 105137, 105215105194, 105195, 105228, 105236, 105235, 105104, 105240, 105368; Model PRECISE ACC, Serial Nos. 105992, 105894, 105563, 105806, 105902, 105627, 105706, 105785, 105821, 105871, 105648, 105655, 105882, 105960, 105754, 105886, 105606, 105585, 105731, 105989, 105727, 105782, 151075, 151077, 151098, 105841, 151099, 105630, 151014, 105895, 105816, 105864, 105846, 1055559, 105657, 105853, 105854, 105829, 151016, 105660, 105844, 105890, 105621, 105587, 151035, 105580, 105809, 105644, 105593, 105705, 105699, 105803, 105723, 105647, 105898, 105369, 105949, 105868, 105998, 105637, 105837, 105636, 105716, 105717, 151029, 105759, 105770, 105772, 105776, 105925, 105568, 105650, 105591, 105929, 105584, 105624, 105941, 105666, 108573, 105926, 105646, 105676, 105260, 105773, 105936, 105872, 105678, 151159, 151030, 105910, 105969, 151015, 105812, 105796, 105950, 105881, 105859, 105728, 105561, 105590, 105612, 105567, 105744, 105566, 105879, 105828, 105856, 105918, 105555, 105610, 105883, 105914, 105990, 105586, 151154, 105649, 105565, 105564; Model SYNERGY PLAT, Serial Nos. 151033, 151216, 151173, 151053, 105826, 151200, 151201, 151116, 151025, 151160, 105982, 151256, 151076, 151110, 151008, 151093, 151229, 105932, 151143, 151038, 151059, 151260, 151130, 151024, 151214, 151167, 151051, 151176, 151080, 151104, 151259, 151238, 151084, 105984, 151155, 151156, 151157, 151074, 151266, 151134, 151141, 151055, 151073, 151178, 151168, 151151; Model SL20, Serial Nos. 105285, 105093, 105321, 105358, 105286, 105295, 105249, 105274, 105288, 105381, 105403, 105323, 105319, 105312, 105316, 105257, 105267, 105207, 105057, 105351, 105327, 105273, 105185, 105339, 105300, 105187, 105382, 105154; Model SL75/5, Serial Nos. 103137, 103172, 103174, 103092, 103091, 103130, 103131, 103124, 103394, 103099, 103159, 103081, 103384, 103026, 103053, 103050, 103110, 103001, 103177, 103161, 103030, 103084, 103064, 103055, 103154, 103399, 103346, 103375, 103027, 103386; Model SL1+, Serial Nos. 105447, 105465, 105518, 105528, 105514, 105478, 105466, 105519, 105498, 105453, 105492, 105467, 105445, 105452; Model SL1, Serial Nos. 105475, 105521, 105549, 105494, 105437, 105503, 105530, 105544, 105488, 105515, 105482, 105532; Model SL75/20, Serial Nos. 273, 266, 269, 274
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    United States, Canada and Mexico.
  • Description du dispositif
    Elekta SL Series/Precise Digital Accelerator. || The product is used with radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
  • 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